AU2021209256B2 - Herbal formulations of carnivorous plants and methods for treating inflammation - Google Patents

Abstract

Formulations and methods for treating inflammation using pitcher plants. The pitcher plant is made into herbal preparations, such as tinctures and infused solutions. The herbal preparation of the pitcher plant is combined with glutathione, solutions, supplements, or other plant preparations to make a composition. Administering the composition to a subject can reduce inflammation, increase fibroblast growth factors, and adjust fibrinogen to homeostatic levels, thereby treating the inflammation.

Description

HERBAL FORMULATIONS OF CARNIVOROUS PLANTS AND METHODS FOR TREATING INFLAMMATION CROSS-REFERENCE

[0001] This application is a divisional application of Australian application no. 2017200088, the entire disclosure of which is incorporated herein by reference. This application claims priority to U.S. Patent Application No. 13/309,144, filed on December 01, 2011, which is a non-provisional of U.S. Provisional Patent Application No. 61/418,692, filed December 1, 2010, and U.S. Provisional Patent Application No. 61/448,824, filed March 03, 2011, the specification(s) of which is/are incorporated herein in their entirety by reference.

[0002] This application claims priority to U.S. Patent Application No. 14/305,933, filed on June 16, 2014, which is a non-provisional of U.S. Provisional Patent Application No. 61/835,741, filed June 17, 2013, the specification(s) of which is/are incorporated herein in their entirety by reference.

[0003] This application claims priority to U.S. Patent Application No. 14/306,581, filed on June 17, 2014, which is a non-provisional of U.S. Provisional Patent Application No. 61/835,749, filed June 17, 2013, the specification(s) of which is/are incorporated herein in their entirety by reference.

FIELD OF THE INVENTION

[0004] The present invention features formulations and methods of treatment using herbal formulations containing carnivorous plants, in particular, pitcher plants such as Sarracenia flava and Sarracenia purpurea.

BACKGROUND OF THE INVENTION

[0005] Historical data on uses of the pitcher plant spp. (i.e. Sarracenia spp.) demonstrate efficacy as a digestive aid and anti-viral (webmd.com, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3302891/), having been employed as a medicine in early pharmacies, but never studied as to the exact effect on the immune system. However, work done on the present invention has identified that the carnivorous plant(s), Sarracenia flava and Sarracenia purpurea (pitcher plant) and mixed hybrids or related species thereof, have the capability to decrease and stabilize fibrinogen levels, and do so quite dramatically.

[0006] Fibrinogen is a precursor acute-phase reactant protein produced by the liver in response to signals of systemic circulating cytokines, possibly as an effort to stimulate a healing reaction within the immune system. It is involved in the creation of clots, atherosclerosis, and generalized inflammation. In the systemic circulation, it gets converted to fibrin, which the present invention has determined can be homeostatically used by fibroblast and myofibroblast cells to heal or build tissues. Excess fibrinogen increases inflammation, cancer and over-deposition of tissues, such as scar tissues. Fibroblast and myofibroblast activities are regulated by proteins called fibroblast growth factors (FGF), of which there are 23 identified currently (Mueller and Fusenig 2011 and Baird and Klagsbrun 1991). These growth factors are dependent on the presence of glutathione, which are found within the growth factors.

SUMMARY

[0007] The present invention features a composition comprising an herbal preparation of carnivorous plants, such as pitcher plants. It is surprisingly discovered that the present composition is effective against diseases that manifest as a result of the deleterious effects of inflammation and cancerous cells.

[0008] During the course of the invention, it was discovered that current lab "normals" for fibrinogen may indeed be flawed. For example, some labs set lab normals as 193-507 mg/dL and physicians read that as saying the clotting pathways are normal and working fine, and below 193 mg/dL means the patient will start to bleed out. Without wishing to limit the invention to a particular theory or mechanism, the present invention has determined that fibrinogen is healthy and ideal when levels are within 165-225 mg/dL, which is defined herein as "homeostatic levels", in order for the patient to live free of inflammatory symptoms. This range can be reached when pitcher plant preparations of the present invention are administered orally. Above 225 mg/dL indicates that the patient may be struggling with a systemic inflammatory process or cancer. For example, tumors tend to start developing once the fibrinogen levels surpass 225 mg/dL. Fibrinogen levels over 225 and into the 300s and above can create excess fibrin, which the body can use to make scar tissue. This fibrin may also be in the tissues of any disease, i.e. cancer, autoimmune conditions, blockages, etc.

[0009] During the course of the invention, it was revealed that fibrinogen levels may be sensitive and can rapidly increase from exposure to small amounts of stress or even processed sugars in the diet. Each of these patients also struggled with inflammatory or cancer-related conditions including, but not limited to, multiple sclerosis, arthritis, cancer, or autoimmune conditions. It is possible that the body can manufacture fibrinogen immediately should the need arise, such as for clotting. Moreover, it is a possibility that people may suffer from medical concerns because their fibroblasts are constantly responding to circulating inflammation, which means that these fibroblasts cells are constantly trying to keep other cells and tissues healthy.

[0010] Like fibrinogen, fibroblast growth factors (FGF) have lab normals that are currently not established, and are insignificant if they appear on the lab. There are 23 known growth factors that can signal cells what tissue to heal or maintain. The growth factors are dependent on glutathione and must have vitamins A and D and magnesium in the extracellular matrix around them in order to signal cells to heal.

[0011] Currently, FGF-23 is the only one that can be checked in conventional labs, its range being 44-215 Ru/mL. Without wishing to limit the present invention to a particular theory or mechanism, the present invention has found that FGF-23 levels below 99 Ru/mL indicate that the patient is a "slow healer". The patient is chronically sick and does not improve easily despite receiving treatments such as chemotherapy and common neutraceuticals. Chronic diseases are likely to develop and set in to the patient. Further, the patient does not get well overall and tends to stay sick, and may likely need medication, surgery, etc. FGF-23 levels from 100-199 Ru/mL indicate that the patient is a "fast healer". FGF-23 levels above 200 could indicate a health condition such as cancer or acute inflammatory conditions. At these levels, the body is trying to heal something but is unable to do so.

[0012] Current medical standards classify high FGF-23 levels to be harmful because the increase in fibroblast growth factors can signify that a disease or disorder, such as cancer, is secreting them to proliferate. In the case of cancer, since the tumors produce fibroblast growth factors as the cell is dying, an oncologist would attempt to decrease glutathione, thereby decreasing and inhibiting fibroblast growth factors production in order to inhibit the tumors. It has been surprisingly discovered that these current medical standards are wrong.

[0013] Without wishing to limit the invention to a particular theory or mechanism, the present invention has surprising discovered that the body is increasing FGFs in an effort to heal. It is believed that the disease is producing what it needs to stimulate healing, yet current medical practices attempt to inhibit this. For example, by increasing fibroblast growth factors production, the tumors can shrink and heal. The composition of the present invention is capable of increasing FGF levels via administering injections of a composition of the present invention, and decreasing fibrinogen levels to homeostatic conditions via administering oral composition of the present invention, thereby treating the disease. Clearly, current medical practices teach away from the concept of increasing fibroblast growth factors production as taught in the present invention.

[0014] Immune cells, or lymph cells, can circulate within the body in a rhythm. Fibroblasts cells can be found in the lymph fluid. Current medical standards teach that minimal blood supply or lack thereof in blood flow to the tissue may be the reason for why the tissue does not heal well. Without wishing to limit the invention to a particular theory or mechanism, the present invention reasons that if there were a lack of blood flow to the tissue, then the fibroblast is collecting in the vicinity of the tissue. Hence, it is another aspect of the present invention to stimulate fibroblast movement in order to promote healing of the tissue. For example, administering topical compositions of the present invention can stimulate movement of the fibroblast, as well as transport nutrients to the FGF and the fibroblast extra-cellular matrix.

[0015] According to one embodiment, the present invention features compositions and methods of treating inflammation. The method may comprise administering one or more injections of a therapeutically effective amount of a composition to fascia and ligaments surrounding a spine of the subject. The composition may comprise an herbal preparation of a carnivorous plant, such as a pitcher plant Sarracenia purpurea, at a range of about 1% to 99% volume of the composition, and a glutathione at a range of about 1% to 99% volume of the composition. The herbal preparation of the carnivorous plant is effective for facilitating transmission of the glutathione to fibroblast growth factors. Moreover, the administering of the composition to the subject can increase fibroblast growth factors at measureable levels in the subject, and adjusts fibrinogen levels to homeostatic levels in the subject, thereby ameliorating symptoms of the inflammation of the subject. Furthermore, the one or more injections are effective for stimulating movement and activity of fibroblast cells via insertion of the injection needle (http://www.ncbi.nlm.nih.gov/pubmed/24593827). The composition may further comprise supplements such magnesium, vitamin D, vitamin A, and glucosamine.

[0016] According to another embodiment, the present invention features oral compositions and methods for decreasing fibrinogen levels to homeostatic levels. The oral compositions may comprise the herbal preparation of the carnivorous plant, such as the pitcher plant Sarracenia purpurea. Patients, when orally administered the composition, see a resolution of inflammatory symptoms via a decrease in fibrinogen levels measureable in blood. Without wishing to limit the present invention to particular mechanism or theory, the pitcher plant is surprisingly discovered to decrease fibrinogen levels to homeostatic levels, as shown by pre- and post-patient labs upon prescribed oral use of the pitcher plant, thereby reducing symptoms of inflammation due to the decrease in fibrinogen levels, and increasing pain-relieving effects.

[0017] In yet a further embodiment, the present invention features topical compositions comprising the herbal preparation of the carnivorous plant, such as the pitcher plant Sarracenia flava. Without wishing to limit the present invention to particular mechanism or theory, the pitcher plant is surprisingly discovered to stimulate movement of fibroblasts. Moreover, the pitcher plant has a transdermal effect, i.e. the pitcher plant is amphiphilic such that it can carry substances, such as magnesium, which is insoluble in fats, into and through the skin.

[0018] It is known that botanicals and nutraceuticals (supplements) have synergistic effects when combined together, for example with regards to the use of Chinese herbs (Xu et al. 2014 and Yang et al. 2009). According to embodiments of the present invention, the composition can be combined with antioxidants such as berries or glutathione, fibroblast protectors such as extracts of orchids, fibroblast motility enhancers such as extracts of lily, immune modulators such as curcumin or black cohosh extracts, and cytoprotectors such as astragalus. The pitcher plant may also be combined with bases such as DMSO (dimethylsulfate, jacoblab.com) or coconut oil, cleansers such as lye for saponification processes, and astringents such as witch hazel.

[0019] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description.

BRIEF DESCRIPTION OF FIGURES

[0020] FIG. 1 shows an MRI image of a brain. The white-colored portion of the brain indicates cancer.

[0021] FIG. 2 shows MRI images of the same brain taken three months later. The patient was administered spinal injections the composition of the present invention during those three months.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0022] According to the International Carnivorous Plant Society (www.carnivorousplants.org), a "carnivorous plant" is a predatory plant that obtains its nutrients by trapping and killing prey. A carnivorous plant has the following features: 1. the plant captures and fills prey; 2. the plant has some mechanism to digest the prey; and 3. the plant absorbs the nutrients from the prey. Some non limiting examples of carnivorous plants include plants from the genus Sarracenia, Dionaea, Utricularia, and Drosera. The preferred carnivorous plants of the present invention are pitcher plants, namely, Sarracenia flava and Sarracenia purpurea.

[0023] As used herein, the term "extract" is defined as a separation of the beneficial (medicinal) components of an herb from the fibrous, less useful part of the plant. Extracts can be in a liquid or powdered form.

[0024] As used herein, the term "infuse" is defined as a procedure of withdrawing nutritive compounds of an herb into a medium, and allowing them to linger in the medium for a period of time to allow for the transfer of herbal extracts into the medium. An "infused solution" is the resulting solution with the nutritive compounds.

[0025] As used herein, the term "tincture" is defined as a heavily concentrated extract made by placing chopped fresh or dried herbs into a container and covering them with a solvent. The mixture is then sealed and allowed to macerate for several weeks.

[0026] As used herein, an "herbal preparation" or a "plant preparation" may be an extract, tincture, or infused solution made or prepared from an herb or plant. The herbal preparation contains the active components from the herb or plant. For example, the herbal preparation of a pitcher plant may be a pitcher plant extract, tincture, or infused solution. A pitcher plant component is extracted from the pitcher plant. As used herein, a "pitcher plant component", or alternatively, an "active component" is defined as the beneficial (medicinal) plant parts/material of pitcher plant. For instance, the herbal preparation of the pitcher plant may be an oil infused with the pitcher plant active component.

[0027] As a non-limiting example of extracting the active components from the pitcher plant, in some embodiments, the pitcher plant is cut into small pieces, pulverized, mashed, or chopped. The pitcher plant pieces are placed in a non reactive storage container, such as glass or plastic. A required amount of liquid, such as water, alcohol, or vinegar, is added to the storage container. The mixture is set aside and allowed to incubate for a period of time. The pitcher plant's active components transfer from the plant material into the liquid. After the incubation period is over, any plant material solids are separated from the liquid. The resulting liquid is the pitcher plant tincture. In another embodiment, a pitcher plant extract is prepared by dehydrating the pitcher plant material and pulverizing or grinding the plant material into a powder.

[0028] As used herein, the term "supplement" are generally understood include, but are not limited to, vitamins, minerals, fiber, fatty acids, amino acids and amine derivatives. As used herein, the term "minerals" may be categorized into two kinds of minerals: macrominerals and trace minerals. Macrominerals include, but are not limited to, calcium, phosphorus, magnesium, sodium, potassium, chloride and sulfur. Trace minerals include, but are not limited to, iron, manganese, copper, iodine, zinc, cobalt, fluoride and selenium. Examples of vitamins include, but are not limited to, retinoic acid (Vitamin A), vitamin B-complex, vitamin C, vitamin D, vitamin E, and vitamin K. Non-limiting examples of fatty acids include phosphocholine, phosphytidylcholine, and phosphytidylserine. Non-limiting examples of amino acids include cysteine and arginine, such as L-arginine. Examples of amine derivatives include, but are not limited to, glucosamine.

[0029] As used herein, "inflammation" is a biological protective response in which the body attempts to remove harmful stimuli, including, damaged cells, irritants, or pathogens, in order to begin the healing process. Inflammation is a component or symptom of numerous diseases and conditions, including but not limited to, cancer, arthritis such as osteoarthritis and osteoporosis, diabetes herniated discs, lesions such as brain lesions, skin lesions, wounds, ulcers, tumors, and sores, skin disorders such as eczema, gastrointestinal disorders such as irritable bowel syndrome, psychological disorders such as depression and anxiety, and cognitive decline such as Alzheimer's and dementia. Symptoms of inflammation include pain, heat, redness, swelling, scar tissue, and loss of function.

[0030] As used herein, the terms "administering" or "administer" is defined as the introduction of a substance (composition) into cells in vitro or into the body of an individual in vivo and includes topical, oral, nasal, ocular, rectal, vaginal and parenteral routes. The composition of the present invention may be administered via any route of administration, including but not limited to topical, subcutaneous, intramuscular, intravenous, intradermal, or orally. For example, the composition can be administered by needle injections into the fascia and ligaments surrounding the spine. As known to one of ordinary skill in the art, ligaments are fibrous bands of connective tissue that attach to bone. For example, the supraspinous ligament is a ligament that attaches the tip of each spinous process to the other. The spinous process is a bony projection off the posterior (back) of each vertebra. Other examples of ligaments include the nuchal ligament, which is a ligament at the back of the neck that is continuous with the supraspinous ligament, and the interspinous ligaments, which are ligaments that join the spinous processes along their adjacent borders. As known to one of ordinary skill in the art, the fascia is a strong sheath like connective tissue. For example, the thoraco-lumbar fascia, or lumbodorsal fascia, is a tough, membranous connective tissue covering the muscles of the back of the trunk. In the lumbar region, the lumbodorsal fascia is attached, medially, to the spinous processes of the thoracic vertebrae.

[0031] As defined herein, the terms "treating" or "treatment" of a condition includes: (1) preventing the condition, i.e., causing the clinical symptoms of the condition not to develop in a mammal that may be exposed to or predisposed to the condition but does not yet experience or display symptoms of the condition; (2) inhibiting the condition, i.e., arresting or reducing the development of the condition or its clinical symptoms; or (3) ameliorating or relieving the condition, i.e., causing regression of the condition or its clinical symptoms. The composition can be administered to treat inflammation. As used herein, the terms "treat" or "treatment" refer to both therapeutic treatment or preventative measures, wherein the object is to prevent or slow down (lessen) an undesired physiological change or disorder, such as the development or worsening of inflammation. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, alleviation of symptoms, diminishment of extent of disease, stabilized (i.e., not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable. "Treatment" can also mean prolonging survival as compared to expected survival if not receiving treatment. Those in need of treatment include those already with the condition or disorder as well as those prone to have the condition or disorder or those in which the condition or disorder is to be prevented or onset delayed. Optionally, the patient may be identified (e.g., diagnosed) as one suffering from the disease or condition (e.g., any disease or condition that results in inflammation) prior to administration of the composition of the invention.

[0032] As used herein, Cytenssic means "cell essence, and Cytenssic therapy is a treatment developed in the present invention. The principle of Cytenssic therapy is that the body is able to heal itself via the fibroblast growth factors, and any other related growth factor. The base formulation of Cytenssic therapy is the carnivorous plant and glutathione. Minerals, vitamins, and other anti-cancer herbs can be added to the base formulation. When the FGF levels are increased, inflammation is reduced and the body is able to heal and rid itself of the disease.

[0033] As used herein, the term "therapeutically effective amount" refers to an amount of a compound, i.e. the composition, effective to treat a condition, disease or disorder in a subject. In the case of inflammation, the therapeutically effective amount of the present composition may reduce (i.e., slow to some extent and preferably stop) inflammation, and/or relieve, to some extent, one or more of the symptoms associated with a disorder or disease. The "therapeutically effective amount" will vary depending on the compound, the condition and its severity and body factors such as age, weight, etc., of the subject to be treated.

[0034] As used herein, the term "homeostasis", and derivatives thereof, refers to the ability to regulate variables such that conditions remain stable and relatively constant. For instance, when fibrinogen levels are at homeostasis, the levels are within the healthy range of 165-225 mg/dL, and maintained in that range, as discovered in the present invention.

[0035] As used herein, a "solution" is defined as is a homogeneous mixture composed of two or more substances. A "solute" is a substance dissolved in another substance, known as a "solvent".

[0036] As used herein, the terms "those defined above" and "those defined herein" when referring to a variable incorporates by reference the broad definition of the variable as well as any narrow and/or preferred, more preferred and most preferred definitions, if any.

[0037] Preparing Pitcher Plant Tincture

[0038] In preferred embodiments, the herbal preparation of carnivorous plant is prepared from pitcher plant, such as a Sarracenia purpurea or a Sarracenia flava plant. In alternative embodiments, a tincture may be obtained from other carnivorous plant tinctures. Some non-limiting examples of carnivorous plants are the Drosera species, Dionaea species, and the Utriculariaspecies.

[0039] A pitcher plant tincture is made using a "soak and press" technique. As a non-limiting example, the pitcher plant tincture may be made from a Sarracenia purpurea (pitcher plant). The Sarracenia purpurea material is obtained, preferably from plants grown in the absence of pesticides, and then chopped, forming a "chopped plant mixture". The material may be the leaves, i.e. pitchers, of the plant. In some embodiments, during the harvesting process, the pitchers are cut at the base of the plant, leaving the rhizome. The pitchers may be cleaned such that all detritus and dirt are removed, and assayed for bacterial content (such assays are well known to one of ordinary skill in the art). During the chopping process, the pitchers may be cut lengthwise and/or chopped into strips (e.g., about 1 to 2.5 inch strips). In some embodiments, during the chopping process, the strips may be placed in a blender/chopper.

[0040] The chopped plant material may be placed in a jar or container, e.g., a glass jar. Any appropriate container may be used, for example a glass jar. Clear jars may be used as well as other shaded containers such as amber glass jars. Liquid is added to the chopped plant material, e.g., at a ratio of about 1 gram chopped plant material to about 2 mL liquid. The liquid may be, for example, an alcohol blend. In some embodiments, the liquid comprises an alcohol and water, e.g., distilled water. For example, the alcohol may be grain alcohol such as Everclear.

[0041] The liquid has a ratio of alcohol to water. In some embodiments, the ratio is about 60:40 alcohol to water. In some embodiments, the ratio is about 50:50 alcohol to water. In other embodiments, the ratio is about 40:60 alcohol to water. In still other embodiments, the ratio is about 30:70 alcohol to water. In some embodiments, the ratio is about 20:80 alcohol to water. In other embodiments, the ratio is about 10:90 alcohol to water. In still other embodiments, the ratio is about 70:30 alcohol to water. In some embodiments, the ratio is about 80:20 alcohol to water. In other embodiments, the ratio is about 90:10 alcohol to water. As an example, in some embodiments, about 454 grams of chopped plant material is placed in a jar, and about 908 mL of the liquid (with about a 60/40 ratio of alcohol (Everclear) to distilled water) is added to the chopped plant material.

[0042] After the liquid is added to the chopped plant material, the container is sealed. In some embodiments, the mixture is allowed to incubate for an incubation period, e.g., between about 1 to 2 days, between about 2 to 7 days, between about 1 to 2 weeks, between about 2 to 3 weeks, between about 4 to 6 weeks, more than 6 weeks, etc. In some embodiments, the mixtures are stirred occasionally during the incubation period. The incubation period, or a portion of the incubation period may feature placing the container in a low-light or dark environment.

[0043] After the incubation period, the liquid is decanted off, e.g., with a coffee filter or vacuum. The resultant liquid is the pitcher plant tincture, which may be stored and sealed, e.g., in amber glass bottles.

[0044] The following is a non-limiting example of making a Sarracenia tincture:

[0045] 1. Cut the Sarracenia pitcher plants lengthwise and then chop into 1-2 1 inch strips.

[0046] 2. Blend the plant material with a small amount of liquid. The liquid is about a 60/40% blend of Everclear to distilled water.

[0047] 3. Place the chopped herbs in glass jars in a quantity of about 454 grams.

[0048] 4. Measure about 908 mL of a liquid of about 60/40% Everclear to distilled water and poured over the chopped plant material.

[0049] 5. Seal the jars and let sit for about 4 to 6 weeks in a dark room.

[0050] 6. Occasionally stir the jars.

[0051] 7. After the plant material has sat for about 4 to 6 weeks, the liquid is decanted off with a coffee filter or vacuum.

[0052] 8. The resultant liquid is stored in amber glass bottles and sealed.

[0053] Pitcher Plant Infused Solution

[0054] In some embodiments, a Sarracenia infused solution is made from a Sarracenia tincture. The Sarracenia tincture is mixed with a solvent and distilled for a period of time to remove the alcohol. In some embodiments, distilling the Sarracenia tincture and solvent mixture infuses the solvent with the Sarracenia component. In some embodiments, the solvent is oil or glycerin. In some embodiments, the oil is a carrier oil such as castor oil and coconut oil. When using oil as a solvent, the resulting solution is a Sarraceniainfused oil.

[0055] In some embodiments, the ratio of Sarracenia tincture to solvent is between about 30:70 to 60:40. In other embodiments, the ratio of Sarracenia tincture to solvent is between about 30:70 to 40:60. In still other embodiments, the ratio of Sarracenia tincture to solvent is between about 40:60 to 50:50. In some embodiments, the ratio of Sarracenia tincture to solvent is between about 50:50 to 60:40. In other embodiments, the alcohol in the tincture is grain alcohol, such as Everclear.

[0056] In one embodiment, distilling the Sarracenia tincture and solvent mixture comprises placing the Sarracenia tincture and solvent mixture in a storage container; capping the storage container with a cap having at least one aperture and at least one tube, placing a tube second end in a collection container; heating the Sarracenia tincture and solvent mixture to a temperature at about a boiling point of the alcohol to vaporize the alcohol; and collecting the alcohol vapors in the collection container. In some embodiments, the period of time for distilling the Sarracenia tincture and solvent mixture is between about 1 to 3 hours, such as 1-2 or 2-3 hours. The temperature of distillation can be about 75 °C and 90 °C, such as about 75 °C and °C, 80 °C and 85 °C, or 85 °C and 90 °C. In some embodiments, a heat source for the distillation process is a hot plate, a stove, or a burner.

[0057] The following is a non-limiting example of making a Sarracenia infused solution:

[0058] 1. Measure about 500 mL of Sarracenia spp. tincture

[0059] 2. Measure about 500 mL of solvent

[0060] 3. Pour both into an Erlenmeyer flask.

[0061] 4. Top the flask with a rubber stopper that has tubing coming out of the stopper and into a large glass collection container.

[0062] 5. Place the flask on a heat source, such as a hot plate.

[0063] 6. Heat the flask containing the mixture on low or low-medium heat for about 1-2 hours and monitor flask. As it heats, the alcohol in the Sarracenia spp. tincture will evaporate off and could blow off the rubber stopper if the pressure inside the flask exceeds the evaporation. If this is the case, then lower the heat.

[0064] 7. After about 1-2 hours, the alcohol will be evaporated off and the oil or liquid base will be completely infused with the healing properties of the carnivorous plant.

[0065] FORMULATIONS AND METHODS OF TREATMENT

[0066] The present invention features a treatment designed to stimulate a healing response/cascade to circulating levels of inflammation by increasing fibroblast growth factor levels while simultaneously bringing fibrinogen levels to homeostatic levels, therefore alleviating patient symptoms related to pain and inflammation. As used herein, said treatment is referred to as "Cytenssic therapy", in which Cytenssic means "cell essence". This therapy utilizes various combinations of formulations that synergize the pitcher plant extracts, or other carnivorous plants herein, with known antioxidants, anti-inflammatory herbals, bases, injectables, nutraceuticals (supplements) or mixtures thereof. The mode of administration to the patient may be selected by a physician of ordinary skill in the art.

[0067] Referring now to FIGs. 1-2, according to one embodiment, the present invention features a method of treating inflammation in a subject. The method may comprise administering one or more injections of a therapeutically effective amount of a composition to fascia and ligaments surrounding a spine of the subject. Preferably, the one or more injections may be administered at a depth of about1 inch into the skin. For example, the one or more injections of the composition may be administered into the Du Meridian acupuncture points, du14-2, using a 30g, 1 inch needle. In preferred embodiments, the composition may comprise an herbal preparation of a carnivorous plant, and a glutathione. In one embodiment, the herbal preparation is at a range of about 0.1% to 99% volume of the composition. In another embodiment, the glutathione is at a range of about 0.1% to 99% volume of the composition. Without wishing to limit the invention to a particular theory or mechanism, the herbal preparation of the carnivorous plant is effective for facilitating transmission of the glutathione to fibroblast growth factors. Moreover, the administering of the composition to the subject can increase fibroblast growth factors at measureable levels in the subject, and adjusts fibrinogen levels to homeostatic levels in the subject, thereby ameliorating symptoms of the inflammation of the subject. Furthermore, the injections may be effective for stimulating movement of fibroblast cells. When utilizing the method described herein, after administering the injections, the fibroblast growth factors increases to high levels until healing is accomplished. When the treatment is complete, the FGF levels then decrease to FGF homeostatic levels in the 100-199 Ru/mL range.

[0068] In some embodiments, the herbal preparation of the carnivorous plant is prepared from a pitcher plant, such as Sarracenia purpurea. However, it is understood that any carnivorous plant may be used for the herbal preparation.

[0069] In other embodiments, the composition may be administered at a dosage of about 8 to 20 cc every 4 weeks. For example, the composition may be administered at about 9 cc, depending on the tolerance of the subject, and then increased at each subsequentdosage.

[0070] In one embodiment, the composition may further comprise one or more supplements, at a range of about 0.1-99% vol of the composition, selected from a group consisting of vitamins, minerals, essential fatty acids, amino acids, and amine derivatives. The herbal preparation of the carnivorous plant may be effective for facilitating transmission of the one or more supplements to the fibroblast growth factors. Examples of vitamins include, but are not limited to, retinoic acid (Vitamin A), vitamin B-complex, vitamin C, vitamin D, vitamin E, and vitamin K. Examples of minerals include, but are not limited to, calcium, phosphorus, magnesium, sodium, potassium, chloride, sulfur, iron, manganese, copper, iodine, zinc, cobalt, fluoride and selenium. In some embodiments, the amine derivative may be glucosamine. In other embodiments, the amino acid may be cysteine or arginine, such as L-arginine.

[0071] In a preferred embodiment, the supplement is magnesium and salts thereof. Without wishing to limit the present invention to a particular theory or mechanism, when the subject has low levels of magnesium, symptoms of the subject's disorder can flare. By increasing magnesium levels, the symptoms decrease and the subject starts to heal. For example, the composition in combination with magnesium chloride may be administered to the subject by injection into or at the spine to increase magnesium levels, thereby alleviating muscle pain, twitching, and spasms. In addition, the presence of pain can signal that the subject has low levels of glutathione and/or magnesium. Hence, by correcting the glutathione and/or magnesium levels, the subject can experience pain relief.

[0072] In yet another embodiment, the composition may further comprise a thyroid hormone. For example, the composition in combination with thyroid hormone at a range of about 0.1-99% vol of the composition, i.e. about 5-15% vol of the composition, may be administered to the subject by injection into or at the spine.

[0073] According to an exemplary embodiment, the composition may comprise the herbal preparation of Sarracenia purpurea at a range of about 0.1-99% vol of the composition, glutathione at a range of about 0.1-99% vol of the composition, magnesium at a range of about 0.1-99% vol of the composition, vitamin A at a range of about 0.1-99% vol of the composition, vitamin D at a range of about 0.1-99% vol of the composition, L-arginine at a range of about 1-99% vol of the composition, glucosamine at a range of about 0.1-99% vol of the composition, and a thyroid hormone at a range of about 0.1-99% vol of the composition.

[0074] In some embodiments, the composition may further comprise one or more of the following: aloe vera gel, glycerine, natural oils, an emulsifier, menthol crystals, berries, green tea extract, medicinal mushrooms, turmeric, ginger, viscum, burdock, devil's claw, boneset, valerian, skullcap, marshmallow root, mullein leaf, elecampane root, fennel seed, licorice root, old man's beard lichen, orange peel, osha root, wild cherry bark, propolis, ginkgo, poppy, polygonum, hops, passionflower, avena, and arnica.

[0075] In other embodiments, the composition may further comprise a therapeutically effective amount of one or more plant preparations selected from a group consisting of an astragalus preparation, a curcumin preparation, a black cohosh preparation, an Orchidaceae plant preparation, a Lilium plant preparation, a Sanguinaria canadensis preparation, and a berry preparation. The berry preparation may be an antioxidant. The Orchidaceae plant preparation may be a fibroblast protector. The Lilium plant preparation may be a fibroblast motility enhancer.

[0076] In still other embodiments, the composition may further comprise one or more solutions selected from a group consisting of a witch hazel solution, a lye solution, a salt solution, coconut oil, a dimethyl sulfate (DMSO) solution, and a gelatin.

[0077] In further embodiments, the composition may further comprise one or both of an adrenal formulation and an immune formulation. In one embodiment, the adrenal formulation may comprise withania at about 30% vol of the adrenal formulation, rhodiola at about 25% vol of the adrenal formulation, licorice at about 15% vol of the adrenal formulation, milky oats at about 10% vol of the adrenal formulation, ginseng at about 10% vol of the adrenal formulation, gota kola at about 5% vol of the adrenal formulation, and lemon balm at about 5% vol of the adrenal formulation. In another embodiment, the immune formulation may comprise LIVIXIR at about 30% vol of the immune formulation, astragalus at about 15% vol of the immune formulation, elderberry at about 10% vol of the immune formulation, hydrastis at about 10% vol of the immune formulation, echinacea at about 10% vol of the immune formulation, usnea at about 5% vol of the immune formulation, and inula at about 5% vol of the immune formulation.

[0078] In some embodiments, Cytenssic therapy may involve the administration of a series of injections to the joint space, tendon, ligament, or muscle. A systemic effect is seen when a pitcher plant injectable is mixed with glutathione for injection into the spinal area, and placed via needle manipulation in the tissue to be affected, such as a ligament, tendon, or any other kind of connective tissue surrounding the spine. For example, when the needle is placed at or near the joint space, it can affect healing as shown by a reduction in local scar tissue and pain responses. Systemic effects may be noted by a patient's reaction such as hot flashes, chills, low-grade fever, or mineral salt cravings within a short time period after receiving injections if nutrient levels in the extra-cellular matrix are low.

[0079] Glutathione is a known antioxidant, but it also has residence on two cysteine residues within fibroblast growth factors, in particular FGF-2 (Mueller and Fusenig 2011). The invention shows that modulation of FGF activity is glutathione dependent, as low levels of glutathione prevent a healing response that is permanent. Therefore, the synergetic effects of pitcher plant and glutathione are needed for Cytenssic therapy injections.

[0080] TRANSDERMAL EFFECT

[0081] In other embodiments, Cytenssic therapy involves the pitcher plant combined with any topical agent designed to soothe or heal the skin from inflammatory, arthritic or cancerous conditions. Inflammatory healing reactions involve the transformation of fibroblasts into myofibroblasts. The myofibroblasts use a high amount of the fibrin from fibrinogen, and are only active for acute conditions. However, if the inflammation continues for long periods of time, myofibroblasts stay in the area, which is commonly the case for cancerous tumors and metastasis (Mueller and Fusenig 2011).

[0082] According to another embodiment, the present invention features a topical composition comprising an herbal preparation of a pitcher plant. In one embodiment, the herbal preparation of the pitcher plant is at a range of about 1% to 99% volume of the composition. The composition may be effective in reducing inflammation and stimulating movement and activity of fibroblasts. In some embodiments, the topical formulation may be in prepared as a viscous emulsion, such as a lotion, cream, oil, balm or gel. In preferred embodiments, the pitcher plant is a Sarracenia flava plant. Sarracenia flava is supposedly toxic since it contains the neurotoxin, coniine. However, the present invention has discovered that topically administration of the Sarracenia flava preparation to mammals can induce healing effects.

[0083] In some embodiments, the topical composition may further comprise glutathione at a range of about 0.1-99% vol of the topical composition. In other embodiments, the topical formulation may further comprise one or more of the following: aloe vera gel, glycerine, natural oils, an emulsifier, menthol crystals, berries, green tea extract, medicinal mushrooms, turmeric, ginger, viscum, burdock, devil's claw, boneset, valerian, skullcap, marshmallow root, mullein leaf, elecampane root, fennel seed, licorice root, old man's beard lichen, orange peel, osha root, wild cherry bark, propolis, ginkgo, poppy, polygonum, hops, passionflower, avena, and arnica.

[0084] In other embodiments, the topical composition may further comprise a therapeutically effective amount of one or more plant preparations, at a range of about 0.1-99% vol of the topical composition, selected from a group consisting of an astragalus preparation, a curcumin preparation, a black cohosh preparation, an Orchidaceae plant preparation, a Lilium plant preparation, a Sanguinaria canadensis preparation, and a berry preparation. The berry preparation may be an antioxidant. The Orchidaceae plant preparation may be a fibroblast protector. The Lilium plant preparation may be a fibroblast motility enhancer.

[0085] In still other embodiments, the topical composition may further comprise one or more solutions, at a range of about 0.1-99% vol of the topical composition, selected from a group consisting of a witch hazel solution for astringing the tissues, clay for drawing out toxins, a lye solution for producing soap products for additional cleansing, a salt solution such as epsom salts for mineral balance, a dimethyl sulfate (DMSO) solution for additional absorptive benefits, coconut oil, and a gelatin.

[0086] In yet other embodiments, the topical formulation may further comprise one or more supplements, at a range of about 0.1-99% vol of the topical composition, selected from a group consisting of vitamins, minerals, essential fatty acids, amino acids, and amine derivatives. The vitamins may be selected from a group consisting of retinoic acid, vitamin B-complex, vitamin C, vitamin D, vitamin E, and vitamin K. The minerals may be selected from a group consisting of calcium, phosphorus, magnesium, sodium, potassium, chloride, sulfur, iron, manganese, copper, iodine, zinc, cobalt, fluoride and selenium. The amine derivative may be glucosamine. The amino acid may be cysteine or arginine.

[0087] Without wishing to limit the invention to a particular theory or mechanism, it has been surprisingly discovered that when applied topically, the herbal preparation of the pitcher plant creates a transdermal effect, i.e. the herbal preparation of the pitcher plant can deliver substances across and through the skin. For instance, magnesium is a mineral that is typically insoluble in fats. When magnesium was combined with the herbal preparation of the pitcher plant, specifically a pitcher plant infused oil, magnesium was able to dissolve in the herbal preparation of the pitcher plant. Hence, substances, such as minerals, vitamins, and others that are insoluble in fats, can be administered topically via the herbal preparation of the pitcher plant. For example, when the herbal preparation of the pitcher plant, in combination with vitamins and minerals, is administered topically on the subject's skin, the subject will then taste the vitamins and minerals in his or her mouth because the pitcher plant transports the vitamins and minerals through the skin and to the fibroblasts, which are stimulated into movement by the pitcher plant.

[0088] ORAL ADMINISTRATION

[0089] Likewise, oral administration may be implemented for internal support. According to one embodiment, the present invention features an oral composition comprising an herbal preparation of a pitcher plant. In one embodiment, the herbal preparation is a pitcher plant tincture having an alcohol to water volumetric ratio of about 50:50 to 60:40. Preferably, the pitcher plant is a Sarracenia purpurea plant. The oral composition may be effective for decreasing fibrinogen levels.

[0090] In alternative embodiments, the oral composition may further comprise herbs such as orchids for anti-senescence fibroblastic support or lily extracts for enhanced fibroblast motility. Oral administration of the composition may also be anti inflammatory when the pitcher plant is combined with herbs such as curcumin or black cohosh. Astragalus may be combined with the pitcher plant for cytoprotective effects, or berries for additional antioxidant effects. In preferred embodiments, the oral composition may be administered to the subject at a dose of about 1-2 tsp per day or 1 Tbsp per day for two months in order to decrease fibrinogen to homeostatic levels.

[0091] DROP THERAPY

[0092] In alternative embodiments, the herbal preparation of the pitcher plant may be used in acupuncture. The acupuncture needle is dipped in the herbal preparation of the pitcher plant, and if desired, with another tincture/essential oil, before using the needle in the acupuncture process. This treatment is known as drop therapy. Non limiting examples of essential oils include turmeric, mint, rosemary, cinnamon, frankincense, and basil. For example, patients with sinus infections will clear the infection better with the drop therapy than just acupuncture alone. Without wishing to limit the invention to a particular theory or mechanism, the pitcher plant act can decrease fibrinogen levels to homeostatic levels locally around the insertion site of the acupuncture needle. In addition, fibroblast movement activity and movement is stimulated. In other embodiments, when administering the composition via injection, the injection needle may be dipped in the herbal preparation of the pitcher plant, and if desired, with another tincture/essential oil, prior to injecting the needle. In further embodiments, drop therapy can feature sublingually administering the herbal preparation of the pitcher plant, and if desired, with another tincture/essential oil.

[0093] BURNABLES

[0094] In an alternative embodiment, the pitcher plant may be used in candles and incense. The dried pitcher plant material or the pitcher plant preparation may be used in the candles or incense. For example, a pitcher plant tincture may be immersed into wax such as soy or beeswax. Alternatively, the wax can be infused with the pitcher plant component.

[0095] In another alternative embodiment, the pitcher plant may be smoked by a subject. Smoking of the pitcher plant may be effective for instilling a mild, relaxing mood in the subject. In one embodiment, the dried plant material of the pitcher plant may be smoked directly. In another embodiment, a pitcher plant infused oil may be used in a vaporizing device. Without wishing to limit the invention to a particular theory or mechanism, a limonene component and/or a cannabinoid component of the pitcher plant can induce an anxiolytic effect in the subject.

[0096] In some embodiments, any of the aforementioned compositions may also treat insomnia. The compositions may affect how a person sleeps through the night since it is well-documented that the cytokine Interleukin 6 (IL-6), which can stimulate inflammatory and auto-immune processes in many diseases, is active in people with insomnia. As a non-limiting example, a formula with herbs may contain black cohosh or other herbs that lower IL-6 to obtain anti-insomnia properties.

[0097] EXAMPLES

[0098] The following are non-limiting examples of the present invention.

[0099] Example 1: Oral Administration

[00100] 1. A patient is prescribed to take an oral formulation of an herbal preparation of the pitcher plant, at a dosage of 1 Tbsp, twice/day, for 3 weeks.

[00101] 2. Re-test fibrinogen levels.

[00102] 3. Depending on fibrinogen levels, the patient is prescribed a maintenance dose of 1 to 1 Tbsp/day until fibrinogen levels decrease to normal levels.

[00103] Example 2: Administration by Injection

[00104] 1. Draw patient FGF-23 labs.

[00105] 2. Perform spinal injections of 75/25% pitcher plant to glutathione. Use a 30g 1/2 inch needle applied right below the spinous processes, into the Du meridian acupuncture points, du14-2. The physician can inject at all points or at key points such as 14, 11, 10, 6, 4 and 2, depending on how much scar tissue it felt by the physician and how much injected fluid can be tolerated by the patient. The physician can start with 9 cc total and at other visits, may go up to 18 cc along the spine.

[00106] 3. Do monthly injections, ideally every 4 weeks, to allow for time to heal between and see the symptoms change.

[00107] 4. Check the FGF-23 levels at intervals decided by the physician and patient.

[00108] Example 3: A 39-year old female patient was suffering from fatigue. The physician prescribed a topical cream of vitamins and the herbal preparation of the pitcher plant. The patient reported that she applied the topical cream on her abdomen. Within a few hours, she got flushed as though she took orally a large dose of multi-vitamins or B-complex. The patient reported that she has great energy after taking the topical cream.

[00109] Example 4: A female patient suffers from fibromyalgia. Pre-labs of the patient reported a fibrinogen activity of 326 mg/dL. The patient smokes 1 pack of cigarettes per day. Smoking is known to increase fibrinogen. The physician prescribed 1 Tbsp, twice/day of S. purpurea tincture 60/40. The patient continued to smoke cigarettes while taking the tincture. Post-labs taken 11 days later reported that the fibrinogen activity decreased to 261 mg/dL.

[00110] Example 5: Pre-labs of a male patient shows a fibrinogen activity of 366 mg/dL. Thirty-nine days later, the patient ate copious amount of sugary foods during the holidays, and increased his fibrinogen activity to 404 mg/dL. Sugar is known to increase fibrinogen. Two months later, the patient was suffering from painful irritable bowel syndrome. His abdominal inflammation is further aggravated by eating sugar. His fibrinogen activity increased to 418 mg/dL. His physician prescribed a dose of 1 Tbsp, twice/day of the pitcher plant tincture. Forty days later, the patient reported that his abdominal pain decreased significantly, as did the fibrinogen. His post-lab fibrinogen activity decreased to 357 mg/dL.

[00111] Example 6: A 50-year old female has the genes for cervical cancer. The patient's PAP test results reported: "Atypical squamous cells of undetermined significance, favor low grade lesion. This latter would correspond to mild dysplasia and/or HPV effect." The patient's physician prescribed a vaginal cream of the topical composition to be applied nightly, unless the patient was menstruating. Seven months later, a second PAP test of the patient reported: "Negative for intraepithelial lesion or malignancy. Benign cellular changes with reactive features." The patient no longer has precancerous cells.

[00112] Example 7: A female patient suffered from the starting phases of dementia, osteoarthritis, fibromyalgia and IBS. Pre-labs of the patient reported an FGF-23 level of 99 Ru/mL. The FGF-23 level indicates that the patient is a slow-healer. The patient's physician prescribed a series of injections of the composition at varying ratios, usually 75/25% pitcher plant to glutathione. Labs taken 4 months later reported an increase in FGF-23 levels to 534 Ru/mL. The patient reported that her memory was returning and that she no longer suffered from fibromyalgia and IBS pain. Furthermore, her osteoarthritis was also diminishing.

[00113] As used herein, the term "about" refers to plus or minus 10% of the referenced number.

[00114] Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the invention. Each reference cited in the present application is incorporated herein by reference in its entirety.

[00115] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase "comprising" includes embodiments that could be described as "consisting of", and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase "consisting of" is met.

[00116] By way of clarification and for avoidance of doubt, as used herein and except where the context requires otherwise, the term "comprise" and variations of the term, such as "comprising", "comprises" and "comprised", are not intended to exclude further additions, components, integers or steps.

[00117] Reference to any prior art in the specification is not an acknowledgement or suggestion that this prior art forms part of the common general knowledge in any jurisdiction or that this prior art could reasonably be expected to be combined with any other piece of prior art by a skilled person in the art.

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LabCorpPhamix 5005 S 40th Street Ste 1200 muerAisDNuamba *p LPhoenix, AZ85040-2969 AccoacnNuner Phone; 00-788-9743 camowixamedus~

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F 3 Venipuncte T& atsta rrao RVYEMWs rNnamVayA zAs FGF-23 271 High RUHt/L 44 - 215 01 Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer. The performance characteristics of this assay have not been established by the manufacturer. The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure. The performance characteristics were determined by LabCorp.

01 BN LabCorp Burlington Dir. William F Hancock, MD 1447 York Court, NC 27215-3361 For inquiries the hyician mBurling)t: contact Brancht 922-778-7323 Labi 300-788-9743

08/28/15 14:23 ET FINAL REPORT Page 1 of 1 This deemacnim paivatoecaretn~kdnialumaskmsfonatieroeted byot nd fderala ©200 Mgs 1~5CrLaborryCoeoatin efAnanicda ifyouruvexeceeud d1sdocanmta, plame ca,1 H8-522-2677 AllR;SflRsenvd DOCI Ver 149

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# F-23 Result Reference Date/status Observations 351Ru/mL 44-215 Ru/mL 04/10/2015 08:31am FGF-23 Above high normal Vendor note Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer, The performance characteristics of this assay have not been established by the manufacturer. The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure The performance characteristics were determined by LabCorp.

Performing Laboratory LabCorp BurlintonWillamFHancocisMD,Director(800)762-4344

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LLQ"99QP LabCorp phoeaix 5005 S 40th Street Ste 1200 Phonix AZ*804~2%9 P &)O~7ns-9743 ibeA 02 36550 928210

Measured by Immunotopice HumanFOF-2(C-term) BUSA Kit-22 Results of this test are labeled for research purposes assay t s manufacturer. The performance characteristics only by the have not been established by thelanufacturerk of this assa The result be usedtfortreatment orfor diagnostic purposeswithout should not of the diagnosis byanother medically established confirmation diagnostic product procedure. The performance characteristics were determined by

01 S Lacor~uringon ir:oinlame 2nomk nI ornquirie, the physician macnatcaca9S77-ssLbi 800-7#R-n47

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jonhveaceiedstisdcasansdoemphaecal~fl$ZazenA RpheRavd DOC1Ves:A9 stosterone, Serum )bsetvatlofs Result Reference Date/status 653 ng/dL 3481197 ng/dL 04/29/2015 02:53am estosterone Serum 04/29/2015 02:53am comment: of lean males Vendor note: Adult male reference interval is based on a population up to 40 yearsold. amoglobin Alt observations Result efeneDate/status 4,8-5,6/ Hemoglbin Al c Vendor note increased risk for diabetes: 5,7 - 6,4 Diabetes: >6.4 Glycemiccontrol for adults with diabetes: <7.0

Result Reference Date/status Observations

[ 0,720 ouI 0,450-4 500uU/mL 04/292015 03:45a TSH

Result Reference Date/status Observations FGF-23 *373Ru/fL 44-215Ru/mL 05108/2015 08:24am - ~~Above high normal__________ Vendornote: Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer, The performance characteristics of this assay not have not been established by the manufacturer. The result should be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure. The performance characteristics were determined by LabCorp.

ilucose, Serum Result Reference Date/status observations 92m /dt 65-99 mg/dL 04/28/2015 09:54pm Glucose, Serum :ibrinogen Activity Observations Result ReferenceDtesau 489mg/L 193-507mgfdL 04/30/2015 12:06am Fcbrinoten Actvy Performing Laboratory LabCor Phoenix Brian Poirier, MD, Director (800) 788-9743 LabCorp Burlington, Wilam F Hancock MD, Director (800)762-4344

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Lab Results fo -' n an (Female, LLL na ) Ipracticefusion Free cloud based EHR Patient information Requesting provider Laboratory Patient1D: Name: M$$ Home: MlabCorp Address: Name: LabCorp Order#:

Hemoglobin Alc Observations Result Reference UoM 1Date/Status Hemoglobin l 5,4 4.5,6 % 03/28/201509:33am Vendor note Increased risk for diabetes: 5.7 - 6.4 Diabetes: >64 Glycemiccontrolfor adults with diabetes: <7 FGF-23 Observatiorts eutReferenceI UOM ----------- DateStatus FGF-232 99 L 44-215RumL 0121031 Vendor note Measuredby Im notopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer, The performance characteristics of this assay have not been established by the manufacturer, The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure, The performance characteristics were determined by LabCorp. Fibrinogen Activity Observations Result Reference /eOM Date/status Fibrinogen Activity 317 193-507 mg/dL 03/30/2015 09:21 am Performing Laboratory tabCorp Phoenix, Brian Poirier MD, Director 800)788-9743 LabCorpBurlington, William F Hancock, MD, Director (800)762-4344

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Lab Results for 40 P ewi e(Female, -SO EMN practice fusion Free cloud based EHR

Patient information Requesting provider Laboratory Patient ID: Name: Home: ?1150 Address: Name: LabCorp Order #:

FGF-23 Observations Result Reference UOM Date/Status FG F-23 225 44-215 Ru/mL 05/22/2015 03:3 pm Above high normal Vendor note Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer. The performance characteristics of this assay have not been established by the manufacturer, The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure. The performance characteristics were determined by LabCorp.

Fibrinogen Activity Obserations Result Date/Status sReference/Uo Fibrinoen Activity 302 93507mg/dl 05109/201506:56am

PerformingLaboratory LabCor Burington, William F Hancock MD, Director (800) 762-4344

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Lab Results for (practice fusion Free coud based EHR Patient information Requesting provider Laboratory Patient 10 Name: Home: Address; Name: LabCorp Order#: U m

FGF-23 Obserations Result Reference I UoM FGF-23 j*534 44-215 RU/mL Date/Status 7/31/201503:1pm Above high normal Vendor note: **Results verified by repeat testing** Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer, The performance characteristics of this assay have not been established by the manufacturer. The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnstic product or procedure. The performance characteristics were determined by LabCorp,

Fibrinogen Activity Observations Result Reference/tUaM Date/Status FibrinogenActivity 329 193-507mg/dl 08/01/2 005am

Performing.Laboratory LabCorp BuringtonWilliam F Hancock MD, Director(800)762-4344

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Patient information Requesting provider Laboratory PatientID: Name, Home: V . I

. Address Name, LabCorp gOrder# 0

FGF-23 Observations Result Reference/ UoM Date/Status FGF-23 0335 44-215 Ro/mL 0/14/2015 038 pm Above high normal Vendornote, Measured by Immunotopics Human FGF-23(C-term) ELISA Kit

Results of this test are labeled for research purposes only by the assay's manufacturer. The performance characteristics of this assay have not been established by the manufacturer. The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure. The performance characteristics were determined by LabCorp.

Performing Laboratory LabCorp urinton, William F Hancock MD, Director (800) 762-4344

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PATIENT INFORMATION

Age: 50 yea, Female Date of Birth Location/lD: PRIVATE OFFICE

PHYSICIAN SPECIMEN INFORMATION BRANDIE GOWEYNMD 3011 N WEST ST. Collected: 04/15/2015 FLAGSTAFF, AZ 86004 Received: 04/15/2015

HISTORY MATURATION INDEX SPECIMEN SOURCE I SPECIMEN VIAL ESTROGEN EFFECT (HORMONAL PATTERN): COMPATIBLE WITH NO CLINICAL INFORMATION PROVIDED AGE AND/OR HISTORY.

CYTOLOGY/PAP TEST Date Reported: 04/17/2015

ATYPICAL SQUAMOUS CELLS of UNDETERMINED SIGNIFICANCE (ASCUS), FAVOR LOW GRADE LESION (LSIL). This latter would correspond to mild dysplasia and/or HPV effect. Please repeat PAP and/or consider tissue confirmation Satisfactory for evaluation. Eridocervical or transformation zone components present 4t Pathtwogist 30OH Co#PAG* OD, MI1M DIaato

3q Gain oncoFISH TEST Date Reported: 05/06/2015 Of 321nucel examined, 2 nuclei with gain POSITVE of 5 or more copies of 3q signal were a>2 nuclei . ithgain.of>=5cop.es .3q noted. Thisis consistent with 3q gain. orphomeric analysis, in situ hybridization performed using computer assisted technology, the Ikoniscope, CLINICAL SIGNIRCANCE Gain of3qand amplification of TERC may predict progression from cervical intraepitieial neoplasia (C1N/ClM2) to CIN3 and invasive carcinoma. Suggest close surveillance of this patient, PateWat300 COPAomo AXnREICAL IRCrTo 1 Ptt Nnt ; d oodatSf v. Htntthrta aeroj nt, tC rdA n rone.C5?47cMe ctx. fax, S n wma ta .' HaeC .T M iss t. Noo !i r .A nt~uteng tcemttagonz ! N:ha w.tr4 44Ny.~me ppetetx..e

WCL72lrd Nohel 90Ve, Hercl's, CA94547 tollfneea00 794.9?37 fax 510.662.5240 www.wcpitcom Jconccmpagno, M.D.,Mediale Drectcr

Page1I PATIENT INFORMATION

Age: 50 years, Female Date of Birth: Location/ID; PRIVATE OFFICE

PHYSICIAN SPECIMEN INFORMATION BRANDIE GOWEY, NMD Accession

# 3011 N WEST ST Collected: 11/24/2015 FLAGSTAFF, AZ 86004 Received. 11/3012015

HISTORY MATURATION INDEX SPECIMEN SOURCE: I SPECIMEN VIAL ESTROGEN EFFECT (HORMONAL PATTERN): COMPATIBLE WITH NO CLINICAL INFORMATION PROVIDED AGE ANDIOR HISTORY,

CYTOLOGY/PAP TEST Date 12/07/2015

NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY, BENGN CELLULAR ,I CHANGES with REACTIVE FEATURES Theschanges may respond to local treatment if 4o clinically appropriate This case may be re-reviewed for quality assurance purposes. Scant epithelialcellularity suggests limited sampling. Please consider repeat collection of cytology if clinically appropriate Consensus Recommn~datln:Repeat both tests In 642 months or sooner as suggested by the ACOG Guidelines (2007,197 (4) 346-355,2007); ASCCP Algodthms (LGTD 2013; 17(5) S1-S27),

FATOLOMST SJO$N COMPAON4N N

HUMAN PAPILLOMAVIRUS DETECTION &GENOTYPING ASSAY BY PCR DateReported: 12/0312015 This sample is positive for the following HPV type(s) (52, 59), This HPV HPV Type E52,59 E infection is considered a high risk for development of dysplas or neopiase of the anogenital tract. HPV of the anogenita tract has implications for the development oforganspecific cancers such as cervical, anal, or oral carcinoma, The diagnosis of dysplasie and cancer are based on the morphologic assessment of the cytology or tissue obtained from biopsy

MPORTANT NOTE l Th u ost'en as psisten h i isHV viraeDNA important rakfactor or ysssir. Peseecorrelate diirvcaiiyvoimPegsmear results and clinca setting PhatdogatJOHNCOPAmO, D

Note;The flowin tests are available for 60 days postieacton if specimen submitted as iquid cytology.Pleasecoll 0 S00 74- 9737 for additionit testing if desired: HIMANPAKLLOMA VRUS (HMP, HERPESWPtLKi VRUS Rt), CHIAMYDA/GNOARHA (CT), SACT UAL VAGNSIS CANDDASAPCIES, TRZCfOMONAS VAGINAUS' ,

Nazila Mejazi, MD

WCPL, 72Alifred NobelDrive, Hercuies, CA 94547 toll tree 800394.973? fax 510&2.5240 www.wcpi.rom 2hni Compagpno, M., Medical Director

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PATIENT FACLUTY ENCOUNTER DOB It NOTE TYPE SOAP Note AGE 53 yrs SEEN BY Brandie Gowey SEX Male NMD PRN JK407916 DATE 12/07/2015 AGE AT DOS

hf complaint ymph nodes

Subjective His ymphnodes aren't swelling, No longer notices them in his arm pits, Prior to startingthstreatmentthenodeswere progressively growing. hstetettendswr

He is getting chills at night and the foot neuropathy is back. Objective

pt was very cold when he presented to the office but fell to sleep during thediathermy

bilateral inguinal nodesarenot enlarging;they are hard but mobile and staying at 1 cm Assessment suspect the inguinal nodes may be scar tissue. diagnoses attached to this encounter: Non-Hodgkin's lymphoma of skin iCD-9:202.88,ISNOMED: 448447004 Hodgkin's disease (clinical) iCD-9:201.90, [SNOMED: 118599009 Degeneration of lumbar intervertebral disc CD-9: 722,521,

[SNOMED: 26538006] Secondaryperipheralneuropathy[10-9:356,9],[SNOMED:385006] Superficial mycosis [CD-9:117,9],ISNOMED: 276206000

Ian Ve willrepeat the pet scan when he no longer has chills or other systemic reactions/symptoms

diathermy x 60 min with epsonVCT oil wet wrap

*attiepraIicteusion.comappenhk 3 85 4 7 3 #iaPcaypetsiMSb innwd mSample Report byHPLC Analysis he Prepared for Sample 1 A?410041-01 CprtifkcattouDats; 10/2214 CerdfeaticnExpationz llflt0M TOW MeIbe W4ght W/A c~k4~amros0.90 'THCV <1,0 -01x0 Om CDA 4.0 <040 C ~ <0 010 A1 CA 1.0 -0.10 0

IdNCtal? 0.10 050

CANtNA4WIQ4OTOTALS MdI MAO 010 tjC1 tM tO 1 01010-0 <cto 910 <1.0 4.0 etO <t <to4 iTal Atthee CannbiomIs <64 <0 TOtaW CaMoia 4.0 <0o0

[muIGOA tCsetsiCIN/ACC

Alpha- ient umom 4001 T" 0tkoe <01 <0.01 jBrCet yophyttne 0. Alh-uoee00101

MitENMATSRAt Pnsegg -. 0.0

Pesticide Seent Not Not Tend Tested oo~~o ~.0

Mwtn Nethtd WA Te-ste&d Ethne Not Tested Notlsted Propene Not""stedMatested Isobutmne Not Tested Notlested nEutwan NotTested Not Tested danhf Not Tested Not Tested Acetone Not Tested Net"Teted Isoprop$ Alcho Not ested t Tested oetant Not Tested Nt Tested retanar Na Teste Nvt Tened eNnmes NotTested NetTested

Ntes As of cdater st1014, rWts fritet Bmit ib change to5p5

PRMtGED AND CONFIDENTLY t azmedSample Rej PCrn l Prepared for'Sample Ubh0 Az1410041-02 1-iitonMe V/W20.14 f cm<2.0 4,010ao

"<1.0 rf <1.0 <zoIo

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12/302019:36:45 AM PROM LASCORP LCLS ULK TO 86639$741 LASCORP Page I of 3 r TO:

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CBC Withitectalltltstaie l);Z;4,*;pahEwtinnl( V4ain 12 andZ'oese: etosteroe, sorUecls ~AIe; TSU; PtO~tate-SpecficcAg, $or=-, Zhyrcxeine tT41; T3 Uptake; Triloothsyrortnt (T3),; Thyroid Prxdn(O)K;VenS5tpsntuze

IC~cWith 01raia/la~e WBQ. 46 .5x1053uL 3.4 - 10.e 01 R30 4.$0 xlOF46/UL 4.14 -5.80 01 Hemoglobin 14.6 g/dL 12.6 - 17.7 01 Rematorit 03.6 1 37,5 -5110 0.1 mcv 91 f79-97 01 MH30.4 P9 26.6 - 23.0 01 23135 /- 31.5- 35.7 01 XRDW 13,7 % 12.13-215.4 01 platelets 276 150 379 01 Neutrophlle 56 101 Lymphs 35 01 /ono/ytes 7 p 01 n 2a 2 01 Easos MCB~~~. 3040 101 )eutrophc s(Ab solute) 26 g X1dty/UL 66 1.4 3,0 7.0 01 ymph (Absolute) 1.6 x10E3/ut 0.7- 3.1 01 MonoCytee(Absolute) 0.3 x103/uL 0.1- 0.9 01 So (Aboolute) 0.1 xgE3/UL 0- 0,4 01 Eaao (Absolute) 0.0 0I.0/t o 0.2 01 lnmat3re Granulocytes 0 , 01 mtureGrass ts) 0.0 X10f3/L 0.0- 0.1 01

Coe serum 390 mg/dL 65 -99 01 tkUW 37 mg/ 6 24 01 Creatinine,serum 1.26 10g/tL 0 7- 37 01 eGFR It NonMriortm 54 ML/Min/1,73 > 5911 eGR If Aricn Am 74 mLmn173>$9 DNu/CreatinineRatio 16 o20 Sodim, seru 143 mol/L 134- 144 01 Potassium, serum 4.5 mol/L 3.5- 5.2 01 Chloride, Sorum 105 xo1E/ L97 - 10S 01

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12/30/2015 9:36:45AM FROM: LACORP LCLS BULK TO:8663957841 LABCORP Pag 2 of3 TO:

UbC Phnix 5005 treetSt200 PheriAZ 85040-2969 Phone:Sktl-788-9743

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Carbon Dioxide, Total 21 mol/L 18- 29 01 Calcium, Serum 9.1 mg/di 8.7- 10.2 01 Phosphorus, Serum 4.0 mg/dL 2.5- 4.5 01 Albumin, Serum 4.3 g/dL. 3.5- 5.5 01

Lipid Panel Cholesterol, Total 193 mg/dL 100- 199 01 Triglycerides 51 mg/dL 0- 149 01 EDL Cholesterol 65 mg/dL >39 01 Comment 01 According to ATP-It Guidelines, HDL-C >59 mg/dL is considered a negative risk factor for CD. VLDL Cholesterol Cal 10 mg/dL 5 - 40 LDL Cholesterol Cale 118 High mg/dLt 0 - 99

Hepatic Function Panel (7) Protein, Total, Serum 6.3 g/dl 6.0 8.5 01 Bilirubin, Total 0.3 mg/dL 0.0 - 1.2 01 Bilirubin, Direct 0.10 mg/d 0.00 - 0.40 01 Alkaline Phosphatase, S 54 lU/L 39 - 117 01 AST (SGOT) 35 IU/L 0 - 40 01 ALT (SGPT) 32 lU/l 0 - 44 01

Vitamin 12 and Folate vitamnB12 320 pqg/t 211 - 946 01 Folate (Folic Acid), Serum 11.6 ng/mL >3.0 01 Note1 01 A serum folate concentration of lese than 3.1 ng/L is considered to represent clinical deficiecy

Testosterone, Serum Testosterone, Serea 291 Low ng/dt 348 - 1197 01 Comment: Adult male reference interval is based on a population of lean males up. to 40 erol'WWA

Hemoglobin Ale memg"lobin Ale $7 High 4 4 8 -5.d 01 Please Notet 01 l '.'.diabeemst 5.- 6.4 Diabetest >6.4 Glycemic control for adults with diabetes: <7.0

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Claims (18)

WHAT IS CLAIMED:

1. A composition suitable for treating inflammation, comprising: a. a herbal preparation of a carnivorous plant, wherein the herbal preparation is at a range of about 0.1% to 99% volume of the composition, wherein the carnivorous plant is Sarracenia flava, Sarracenia purpurea, or mixed hybrids thereof; and b. glutathione, wherein glutathione is at a range of about 0.1% to 99% volume of the composition.

2. The composition of claim 1, wherein the composition is formulated for oral administration, topical administration, or intramuscular, subcutaneous or intravenous injections.

3. The composition of claim 1 or 2, wherein the composition is in a form of a lotion, cream, oil, balm, gel, injectable solution, or oral tincture.

4. The composition of any one of claims 1-3, wherein the herbal preparation of the carnivorous plant is prepared from a pitcher plant.

5. The composition of any one of claims 1-4, wherein the herbal preparation of the carnivorous plant is effective for facilitating transmission of glutathione to fibroblast growth factors.

6. The composition of any one of claims 1-5, further comprising one or more supplements selected from a group consisting of vitamins, minerals, essential fatty acids, amino acids, and amine derivatives.

7. The composition of any one of claims 1-6, wherein the herbal preparation of the carnivorous plant is effective for facilitating transmission of the one or more supplements to the fibroblast growth factors.

8. The composition of any one of claims 1-7, further comprising vitamin A, vitamin B-complex, vitamin C, vitamin D, vitamin E, and vitamin K, or a combination thereof.

9. The composition of any one of claims 1-8, further comprising magnesium, manganese, selenium, zinc, or a combination thereof.

10. The composition of any one of claims 1-9, further comprising glucosamine, cysteine, arginine, a thyroid hormone, or a combination thereof.

11. A composition suitable for treating inflammation, comprising: a. an herbal preparation of a carnivorous plant, wherein the herbal preparation is at a range of about 0.1% to 99% volume of the composition, wherein the carnivorous plant is Sarracenia flava, Sarracenia purpurea, or mixed hybrids thereof; b. glutathione at a range of about 0.1% to 99% volume of the composition; and c. magnesium at a range of about 1-99% vol of the composition.

12. The of claim 11, further comprising one or more supplements selected from a group consisting of vitamins, minerals, essential fatty acids, amino acids, and amine derivatives,

13. The composition of claim 11 or 12, further comprising vitamin A, vitamin B complex, vitamin C, vitamin D, vitamin E, and vitamin K, or a combination thereof.

14. The composition of any one of claims 11-13, further comprising manganese, selenium, zinc, glucosamine, cysteine, arginine, a thyroid hormone, or a combination thereof.

15. The composition of any one of claims 11-14, wherein the composition is formulated for oral administration, topical administration, or intramuscular, subcutaneous or intravenous injections.

16. The composition of any one of claims 11-15, wherein the composition is in a form of a lotion, cream, oil, balm, gel, injectable solution, or oral tincture.

17. A method for treating inflammation comprising administering the composition of any one of claims 1-16 to a subject in need thereof.

18. Use of a herbal preparation of a carnivorous plant in the manufacture of a medicament for the treatment of inflammation, wherein the medicament includes the composition of any one of claims 1-16.