WO2004096251A1 - Herbal compositions and methods for effecting weight loss in humans - Google Patents

Abstract

The present invention relates to a dietary supplement for weight loss in humans. Pursuant to the invention, a decoction of a herbal mixture, comprising rhubarb, red saga root, astragalus, turmeric, and dried ginger and various combinations thereof, may be produced as a dry compound and administered for therapeutic weight loss. The invention includes methods of manufacture and administration and also includes the herbal decoction in various forms of administration and in combination with food.

Description

HERBAL COMPOSITIONS AND METHODS FOR EFFECTING WEIGHT LOSS IN HUMANS

FIELD OF THE INVENTION

The present invention generally relates to biochemical compositions, food and dietary supplements, and engineered foods for effecting weight loss and fat loss in humans. More specifically, the invention relates to the field of herbal compositions, especially decoctions and dried or dehydrated derivatives of decoctions for oral administration. In the preferred embodiments, the compositions contain rhubarb and other herbal ingredients in an edible composition provided at a dosage to effect actual weight loss.

BACKGROUND OF THE INVENTION

Body weight and body composition is determined by the competing balance of food intake and energy expenditure. Although both genetic and environmental factors can contribute to obesity, the most common cause of weight gain and an overweight body composition is excessively high caloric intake accompanied by a lack of physical activity. The resulting accumulation of surplus fat places overweight or obese individuals at increased risk of illness from hypertension, lipid disorders, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, certain cancers, and a wide variety of other diseases and undesired physiological conditions, as well as overall mortality. According to a study, the proportion of overweight individuals in the United States increased from 25% in 1980 to 33% in 1991. (Third National Health and Nutrition Examination Survey, 1991). In 1998 the National Institutes of Health reported that over 55 percent of the U.S. population are now considered overweight or obese. (Obesity Clinical Guidelines: NIH Statement 06/03/98, press release). To control weight and body composition, two related, but distinct, processes are considered. First, it is important to reduce the process of weight gain that occurs when caloric intake exceeds caloric consumption. Reduction in the amount of weight gain is desirable to lessen obesity, but does not equate to an actual reduction of the incidence of obesity that would be enabled by a measurable, absolute loss of weight over time. Thus, obesity may be attenuated by reduction of weight gain or reversed by weight loss. Diet, nutrition, and behavior modification programs all play a role in fighting obesity. Also, pharmaceutical drugs have been developed for severe cases. Among the most widely administered drugs are: orlistat, which reduces the amount of dietary fat that is absorbed from the intestine; sibutramine, which suppresses appetite by inhibiting the re-uptake of norepinephrine and serotonin; fenfluramine and d-fenfluramine. which suppress appetite by both releasing serotonin and then inhibiting its re-uptake; and phentermine, which suppresses the appetite by stimulating the release of norepinephrine.

Most weight reduction drugs typically achieve only a 5-10% decrease in body weight. (National Task Force on the Prevention and Treatment of Obesity: Long-term pharmacotherapy in the Management of Obesity, JAMA 276: 1907-15, 1996). In addition, most drags have mild to serious side effects. For example, the once popular appetite suppressant drug "Fen-Phen" (the combination of fenfluramine and phentermine), which gave a 15-20% reduction in body weight, was clinically determined to alter mood and to have significantly increased the risk of heart valve damage. (F. Brenot et al., Appetite Suppressant Drugs and the Risk of Primary Pulmonary Hypertension, N. Engl. J. Med., 335:609-16, 1996). Consequently, after a number of confirmed "Fen-Phen"-related patient deaths, most of the drugs containing fenfluramine have been recalled and withdrawn. (Connolly H.M. et. al, N. Eng. J. Med. 337:581-88, 1997). In 1999 the FDA removed fenfluramine from the market. Other common side effects include dizziness, headaches, rapid pulse, palpitations, sleeplessness, hypertension, diarrhea, and intestinal cramping.

In addition to adverse side effects, current weight loss drugs may be habit forming, as exemplified by drugs containing amphetamines, and the initial weight reducing effect of many drugs wears off over time, requiring increased dosages to maintain weight reduction. The most serious problem, however, is that the lost weight is frequently regained after the drug is discontinued and the fairly limited utility of these drugs is more than offset by the side effects and other drawbacks inherent in their use.

The following table provides a synopsis of some of the characteristics of the most popular weight loss drugs and notes some of the impediments to wide-scale use:

Various natural herbal weight reduction formulas have been suggested as safer alternatives to both prescription and over-the-counter weight loss compounds. Generally, natural herbal compositions are safer, have fewer side effects when properly formulated, manufactured, and administered in regulated doses. Despite the fact that herbs are natural substances, however, some herbal formulas can still be abused. For example, improper administration of herbal weight loss formulas based primarily on ma huang (ephedra) and high caffeine-containing herbs, such as guanrana and kola nut, may result in diminished energy and a depleted body. Use of ephedra by athletes in training has been linked to deaths in very fit individuals and several health care authorities have called for ephedra to be banned altogether. In addition to serious safety concerns, the development of compositions for weight control is complicated by the difference, as described above, between controlling weight gain and effecting actual weight loss. The difference between these outcomes, while both desirable, can be significant and can result from changes in the component formulation of a compositiom, the form of administration, the dosage, or combinations of these facts that cannot always be isolated. Furthermore, new compounds for treatment of humans are often tested in animal models to insure their safety and efficacy. However, while useful for proof of principle, results obtained in animal models can differ from results seen in humans, and even the most promising results in the best available animal models must be confirmed in humans. For example, a number of rat models have been used to study the effect of drugs on obesity. Diet-related obesity can be created in the Osborn-Mendel, Wistar and Sprague-Dawley rats by altering their diets to increase caloric consumption. This is usually accomplished by increasing the percentage of fat in a carefully controlled diet and measuring a series of physiologic parameters that indicate changes in energy metabolism, rate of increase or decrease in weight gain, weight loss, body composition, and other indicia of overall health and the balance between food intake and energy expenditure. These rats experience the increased weight and fat deposition characteristically seen in obese humans. Using these models, compounds that are candidates for agents to control body weight and composition are tested for safety and efficacy. As noted above, drugs that prevent weight gain or cause weight loss in rat models are also typically effective in humans, albeit at a slightly lower level of efficacy. However, with the compositions and methods of the present invention, important differences between the rat model and actual experience in humans are apparent and these differences affect form of composition and dosage. Given the serious problems associated with obesity, and the significant drawbacks associates with many weight loss compounds, a need exists for a safe and effective composition that effects actual weight loss in humans.

SUMMARY OF THE INVENTION

The present invention is comprised of compositions and methods for effecting weight - loss, specifically, herbal -formulations and methods for formulation, manufacture, and administration to reduce weight and to lower blood Hpid and sugar levels. At the physiological level, the compositions alter the balance of food intake and energy metabolism to favor weight reduction and the improvement of body composition by reduction of fat and overall lipid levels. The compositions are comprised of a combination of more than one herb, and specifically chemical extracts from herbs, that are formulated in a special combination such that the individual components are combined for their individual utilities in the weight loss context, as well as for their synergistic effect in the complete composition of the invention. Each herb is identified by its botanical characteristics, as well as by the chemical compounds contained within the plant that may be extracted by chemical manufacturing processes. Accordingly, chemical compounds and individual constituents of the herbs, individually and collectively, that mimic the effect of the herbs and herbal extracts may be substituted for the actual herbs obtained from nature without departing from the spirit and utility of the invention. In a preferred embodiment, the compositions of the invention include another rhubarb that is specially processed in a decoction and used in combination with other herbal compositions and extracts that enhance the physiological utility of rhubarb and its derivatives. In a preferred embodiment, the composition contains the functional chemical components of rhubarb in combination with other agents that allow the ingestion of rhubarb extracts without side effects. In use, the compositions of the invention can be administered orally in a liquid or tablet form and may be combined with food as part of an obesity treatment regimen or as a dietary or fitness supplement. Thus, the compositions of the invention include the herbal compositions described herein in oral dosage form, or in combination with any of the usual pharmaceutical or nutritional media employed in the art for oral liquid preparations, e.g., suspensions, elixirs, and solutions. Generally, media containing water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may also be used for flavor, texture, or shelf-life enhancement. Carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like may be used to prepare oral solids (e.g., powders, capsules, pills, and tablets). Controlled release forms may also be used. Because of their ease in administration, tablets, pills, and capsules represent advantageous oral dosage unit forms, in which case solid pharmaceutical carriers are employed. If desired, tablets may be sugar coated or enteric coated by standard techniques. While the herbs and herb extracts of the invention are naturally derived from plants that are edible, the compositions of the invention can be administered as herbs or direct extracts of herbs, but one or more herbs can also be substituted with the chemical compounds or functional equivalents that are derived from such herbs. For example, one component of an embodiment of the invention is turmeric. The main functional ingredient of turmeric is known to be curcumin, an organic molecule whose structure and function are well known. Thus, consistent with the invention, the turmeric herb may be replaced in some applications with the organic molecule contained therein or structural and functional equivalents that are presently unforeseeable. Moreover, the compositions of the invention can be combined with ordinary foods to enhance the value of the weight control capabilities. For example, the compositions can be mixed with soft drinks, food supplements, candy, or high-energy bars, and virtually any other food that can be supplemented with a powder or liquid. Thus, the invention specifically includes food substances of specific types combined with the composition of the invention in specified forms and quantities.

A preferred embodiment of the herbal formulation is comprised of a combination of rhubarb root and stem (radix et rhizoma rhei), astragalus root (radix astragali), red sage root (radix salviae miltiorrhizae), turmeric (rhizoma curcumae longae), and dried ginger (rhizoma zingiberis officinalis). As noted herein, the compositions of the invention are preferably first formulated as decoctions and the resulting liquid can be dried to a concentrated solid. Various drying methods are known to simply remove water from an aqueous composition, however, depending on the active agents in the aqueous composition, the dehydration technique can affect the structure and function of the active agents. In the present invention, spray-drying and freeze drying are preferred embodiments. The herbal formulations are preferably administered orally in a dosage range that results in a decrease of body weight, normalization of the metabolic rate, and reduction of blood lipid and sugar level. In a preferred experimental application of the invention, rats administered with 5 grams per day of the herbal composition lost about 39% of their pretreated weight and 60% of their pretreated cholesterol level. In the preferred embodiment to effect actual weight loss in humans, a dosage greater than 8 grams per day, is administered. Dosages of approximately 12 grams per day are demonstrated to produce moderate, sustained weight loss.

DESCRIPTION OF THE FIGURES

Figure 1 shows the cumulative weekly weight gain (grams) measured over eight weeks in five groups of rats administered Fenfluremine (FF), a low dosage of one embodiment if the decoction of the invention (DRD-L), a higher dose of the decoction (DRD-H), a pair fed (PF) water-only group with a measured food intake, and a control.

Figure 2 shows weight gain (grams) at the 56 day interval for the five groups of Figure 1.

Figure 3 shows food efficiency measured as grams of weight grain per gram of food consumed for the five groups of Figure 1. Figure 4 shows food efficiency measured as weight gain per calorie of food ingested for the five groups of Figure 1.

Figure 5 shows a dose response curve measuring the percent difference in body weight as a function of five different dosages of the decoction. Figure 6A shows weight gain in rats fed either an obesity-inducing diet alone, or the diet plus the DRD decoction at day 56. Figure 6B shows the same study at day 90.

Figure 7 shows the differences in absolute weight of the animals in the five groups of Figure 1 measured over 56 days.

Figure 8 shows the difference in weight gain of each body composition component over day 56 for the five animal groups of Figure 1.

Figure 9 shows weight change in pounds over 10 weeks for 4 different compositions of the DRD decoctions administered. PLAC = placebo, 6 GSD = six grams per day with the DRD decoction dehydrated by a "spray dryed" process, 6 GFD = six grams per day with the DRD decoction dehydrated by a "freeze dried" process, 12 DFD = 12 grams per day with the DRD decoction dehydrated by the "freeze dry" process.

Figure 10 shows weight change in pounds over 10 weeks for 3 different compositions of the DRD decoction administered. PLAC = placebo 6 G (ALL) = six grams per day where the composition was a combination of product dehydrated by the "freeze dry" and "spray dry" methods. 12 GFD = 12 grams per day with the DRD decoction dehydrated by the "freeze dry" process.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a pharmaceutically acceptable herbal composition, usually administered as a dietary supplement to effect weight loss, to effect a reduction in weight gain, or an alteration in body composition. For the purposes of this invention, "pharmaceutically acceptable" compositions are formulated and administered to be non-toxic to humans and vertibrates, and, when desired, to be used with carriers or additives that are approved for administration to humans and animal species. In a preferred embodiment, the composition comprises a decoction of rhubarb root and stem, (radix et rhizoma rhei), in combination with other compounds or compositions to enhance the tolerance of rhubarb and increase the efficacy and safety of a formulation derived from a rhubarb-containing decoction. These include astragalus root (radix astragali), red sage root (radix salviae miltiorrhizae), turmeric (rhizoma curcumae longae), and dried ginger (rhizoma zingiberis officinalis). When the composition of the invention is added to solid food stuffs, the composition is preferably prepared in a powder form that is constituted from the decoction by conventional techniques. Preferably, depending on the composition and mode of administration, the dosage is greater than 6 grams per day, greater than 12 grams per day and approximately 90 grams and is orally administered on a daily basis. Most preferably, however, between approximately 12 grams and approximately 30 grams is taken orally each day. For ease of reference, the several different formulations of the invention are collectively referred to herein as the "DRD" decoction.

Rhubarb (radix et rhizoma rhei), also known as "da huang" in traditional Chinese medicine, is an anti-inflammatory and diuretic herb whose effectiveness is controlled by the amount used. In the preferred embodiment of the invention, species of the genus Rheum are used, species of the botanical name Rheum tanguticum Maxim ex Balf, and 2 species of Chinese Rhubarb of the botanical name Rheum palmarum L, and Rheum officinale Baill.

From the foregoing, Rheum tanguticum Maxim ex Balf is particularly preferred. When taken in small doses, rhubarb functions as a digestive aid, increases salivary and gastric flow, improves appetite, and cleanses the liver by encouraging bile flow. This cleansing action also encourages the healing process of duodenal ulcers and enhances gallbladder function. Rhubarb has also been described as containing anthraquinones, specifically rhein, emodin, aloe emodin, chrysophanol, and physcion. These compounds are known to exhibit antibiotic functions, and the anthraquinone glycosides (rhein-8-monoglucoside, emodin-6-monoglucoside, aloe emodin- 8-monoglucoside, chrysophanol- 1-monoglucoside, physcionmonoglucoside are known to exhibit diarrheal function. (Chirikdjian J J, et al. Planta Medica, 1983, (48(1): 34). Also, rhein and emodin inhibit tumor growth in mice.

In large doses in humans, rhubarb can be used for emptying the bowels thoroughly. As a gentle laxative, rhubarb strengthens the gastrointestinal tract, and tones and tightens bodily tissues. Although known for its therapeutic properties in treating dysenteric conditions, rhubarb also has a beneficial effect on blood chemistry, enhances blood circulation, and lowers serum cholesterol.

Only roots and root stems of the rhubarb plant are used for medicinal purposes in humans because the leaves are potentially toxic to homo sapiens, hi addition, rhubarb plants from different climatic regions possess different properties. Preferably, the rhubarb roots used in the preferred embodiments of the present invention are those found Longxi in the Garson Province and other areas in North Central China.

As an essential ingredient of the present invention, the rhubarb root plays key roles in reducing fat intake, enhancing metabolism and decreasing blood Hpid or sugar level in humans. The relative weight percentage of the rhubarb in the embodiments of the decoction is between about 18% to 88%, preferably 36% to about 44%. In one particularly preferred embodiment of the present invention, the composition contains 40% rhubarb by weight percentage. Turmeric (rhizoma curcumae longae) promotes blood circulation. In the natural form, curcumin has been described as containing the following compounds: curcumin and turmerone. The most well-characterized component of turmeric is curcumin. Curcumin has the structure shown in (I)

0⁾ where Ri is -OCH₃; R₂ is -OH; R₃ is -H; R₄ is -H; R₅ is -OCH₃; Rg is -OH, and R₇ is H.

Curcumin has the chemical name (E, E) l,7-bis(4-hydroxy-3-methoxyphenyl)-l,6-heptadiene-

3,5-dione. In natural curcumin, the carbon-carbon double bonds are in the trans configuration.

Curcumin is known to inhibit the enzymatic transformation between phosphorylase b and phosphorylase a. (Curcuma longa; S. Reddy S & B.B. Aggarwal, "Curcumin is a Non- Competitive and Selective Inhibitor of Phosphorylase Kinase," FEBS Lett. 341:19-22 (1994)). The anti-proliferative properties of curcumin inhibit tumor initiation induced by benzo[a]pyrene and 7,12 dimethylbenz[a] anthracene (M.T. Huang et al., Carcino genesis 13:2183-2186 (1992); M.A. Azuine & S.V. Bhide, Nutr. Cancer 17:77-83: (1992). Curcumin inhibits the tumor promotion caused by phorbol esters (M.T. Huang et al., Cancer Res. 48:5941-5946 (1998); A. H. Conney et al., Adv. Enzyme Regul. 31:385-396 (1991); Y.P. Lu et al, "Effect of Curcumin on 12-O-Tetradecanoylphorbol-13-Acetate and Ultraviolet B Light- Induced Expression of c-Jun and c-Fos in JB6 cells and in Mouse Epidermis," Carcino genesis 15:2263-2270 (1994) and has been shown to inhibit pp60src (epidermal growth factor equivalent) tyrosine kinase via inhibition of phosphorylase kinase.

Curcumin is an inhibitor of Type I cyclic AMP-dependent protein kinase, the enzyme mainly responsible for activating phosphorylase kinase. The inhibition is competitive with respect to both ATP and the substrate (M. Hasmeda & G.M. Polya, "Inhibition of CyclicAMP- Dependent Protein Kinase by Curcumin," Phytochemistrv 42:599-605 (1996)). Phosphorylase kinase, in turn, increases the migration of inflammatory cells, tumor cells, smooth muscle cells, and other cell types, as discussed above, as well as infectious organisms, increasing both the destructive and proliferative sequelae of the inflammatory response.

In humans, turmeric is also often used to treat conditions such as amenorrhea, dysmenorrhea and other pains in the abdominal region caused by stagnation of blood. In addition, turmeric has antibiotic and anti-inflammatory properties that make it an herbal medicine for a wide variety of other conditions ranging from arthritis to ulcers, flatulence, blood in the urine, bruises, colic, respiratory diseases, chest pains, jaundice, hepatitis, diabetes, menstrual irregularities, hemorrhage, and toothache. It is also effective both as a treatment and a preventive for intestinal parasites.

Even in high doses, turmeric has not been shown to have any toxicity in humans or animals. Curcumin, the compound responsible for turmeric's yellow color, is considered its primary anti-inflammatory component. See Ammon et al., United States Patent 5,401,777, Heng United States Patent 5,925,376. Dimethylbenzyl alcohol, another component of turmeric, benefits the cardiovascular system by normalizing cholesterol, first by reducing it in the blood and then by removing its accumulation in the liver. Turmeric is known for removing arterial plaque, effectively treating anemia, and as a potent hemostatic used to reduce bleeding. Turmeric's antioxidant properties are often regarded as more potent than either vitamin C or E. Turmeric's antioxidant properties also account for its use as a food preservative and an inhibitor of rancidity of fats and oils. Turmeric also promotes digestion and can increase bile output by up to 100%.

The relative weight percentage of the turmeric in the preferred embodiment of the decoction is between about 12% and about 60%, and preferably between about 24% and about 30% of the weight percentage of the herbal composition. In one preferred embodiment of the invention, the composition contains 26-27% turmeric.

Astragalus root (radix astragali) enhances the immune system and helps the human body resist virus infections, particularly in the lungs, by increasing production of interferon, an immune factor that inhibits viral growth. Astragalus polysaccharides, in particular, are known to enhance immune function. The compounds stragaloside I, astragaloside II, astragaloside HI, and astragaloside IV are anti-oxidants, and especially inhibit Hpid oxidation (CA 1987, 107: P195156p). In the natural form, astragalus has been described as containing astragalan, astragaloside I, astragaloside II, astragaloside HI, and astragaloside IV, and astragolin. It also helps eliminate toxins and promote the healing of damaged tissues, including protecting the Hver against chemical damage. In the preferred embodiment, Astragalus or "milk retch root" from the Bantou region of Inner MongoHa is preferred. This species has the botanical name "Astragalus membranaceus Bge. Var. mongholicus."

In addition, astragalus increases the production and activity of white blood cells (i.e., T- cells) specifically involved in fighting disease. Clinical studies have shown that human cancer • patients who take astragalus while undergoing chemotherapy, which severely inhibits natural immune responses, recover faster and Hve significantly longer than controls. Astragalus also eases chemotherapy and radiation side effects and inhibits the spread of tumors.

Astragalus is rich in polysaccharides and contains glycosides, saponins, and essential fatty acids. Moreover, astragalus helps prevent clotting and has systemic vasodilation properties that help prevent coronary heart disease and improve blood circulation. Its heart tonic properties also lower blood pressure, dilate blood vessels, and strengthen the heart. Furthermore, astragalus facilitates digestion and alleviates digestive ailments. It increases the flow of bile and digestive fluids and increases metabolism and helps control diarrhea.

The astragalus plant grows to a height of about 1 meter, with rigid stalks that sprout eight to twelve pairs of leaflets. The medicinal root is covered with a tough, fibrous, yellowish brown skin and is typically sold in flexible shces approximately 15-20 centimeters long. The marrow is yellowish white and has a sweet taste that resembles licorice. The herb is grown mostly in northern China, Japan, and Korea, each region producing its own distinctive variety. All types can be used in formulas calling for astragalus; as noted above, preferred medicinally potent varieties come from inner Mongolia and northern China.

Astragalus also enhances the overall body energy level, thereby helping to compensate for any possible depleted energy which is often caused by weight loss, hi the context of the preferred embodiments of the present invention, astragalus works together with rhubarb and turmeric to achieve a delicate balance point that maximizes weight loss while minimizes energy depletion. The relative weight percentage of astragalus may vary from between about 5% to about 30%, preferably between about 11% to about 15%. In one particularly preferred embodiment of the present invention, the herbal composition contains 13.3% weight percent of astragalus.

Another ingredient, red sage root (radix salviae miltiorrhizae) enhances blood circulation and reduces serum levels of cholesterol and other lipids. Red sage has been described as containing tanshinone I, tanshinone HA, tanshinone IB, isotanshinone I, , isotanshinone π, miltirone, methyl tanshinonate, cryptotanshinone, isocryptotanshinone, dihydrotanshinone, tanshinol I, and tansinol H Tanshinol I and tanshinol II are known to inhibit the proliferation of human tumorous cells (Ryu S Y, et al. Planta Medica, 1997, 63(4):339. Tanshinone exhibits myocardial protection and prevention of myocardial ischemia. It also prevents blood stagnancy in the lower abdomen, especially for those associated with menstrual pain. In a preferred embodiment, red sage root with the botanical name Slvia miltiorrhhiza Bge is used.

In the present invention, red sage root enhances the function of the cardiovascular system and counter-balances a common side effect of many weight loss drags, increased risk of heart stress that can lead to actual tissue damage. The relative weight percentage of this ingredient may vary in a range of between about 5% to about 30%, preferably between about 11% to about 15%). In one particuarly preferred embodiment of the present invention, the composition contains 13.3 % red saga root. Dried ginger (rhizoma zingiberis officinalis) is usually produced by sun-drying the fresh rhizomes, and has been described as containing zingerone, zingiberene, zingiberol, gingerol, shogaol, phellandrene, and camphene. Zingerone, zingiberene, and zingiberol are known to alleviate vomiting and diarrhea, while zingiberene is an anti-inflammatory. In a preferred embodiment, a ginger species with the botanical name Zingiber officinale Rose, is used. When used in an herbal decoction, the dried rhizomes are more potent than the fresh. Ginger aids digestion and assimilation, and is often added to herbal formulas to facilitate rapid dehvery of the other herbs' therapeutic benefits. Ginger contains a digestive food enzyme called zingibain, which exceeds papain (derived from papaya) in digestive potency. Ginger also increases the concentration of the carbohydrate-digesting enzyme amylase in saliva. Further down the digestive tract, ginger improves digestion by activating peristalsis. Ginger can be used to relieve vomiting and to soothe the stomach and spleen.

In addition, research has found that ginger may help prevent strokes and the hardening of arteries. The active ingredient of ginger, gingerol, is believed to inhibit an enzyme that causes blood cells to clot. Ginger also lowers serum cholesterol, improves circulation, reduces platelet aggregation, and is a regulator of blood cholesterol. Ginger is also effective as a diaphoretic to encourage sweating to remove toxic waste and is used to increase kidney filtration.

As an ingredient of the present invention, dried ginger increases tolerance and reduces the side-effects of the remaining ingredients. Its relative weight percentage may vary in a range of between approximately 3% to approximately 16%, and preferably between approximately 6% to approximately 8% of the composition. In one particularly preferred embodiment of the invention, dried ginger constitutes 6-7% of the composition.

Herbal decoctions are produced by a characteristic method of preparing an aqueous extract of specific quantities of herbs. Traditionally, decoctions are prepared in a clay pot, but they can also be prepared in glass, unchipped enamel, high-quality stainless steel, or oany other inert container that does not interfere with the herbs' properties. Decoctions should not be prepared in iron, copper, aluminum, or any other type of reactive metal containers that can alter the chemistry of the herbs. The main advantages of an herb-derived composition prepared by the decoction method are thorough extraction of the herbs' complete medicinal potential, rapid absorption, and swift onset of therapeutic effects when administered. Generally, a rhubarb-water mixture is prepared separately and added to a mixture of at least one of the remaining ingredients having been separately soaked to form an herbal mixture. When the herbal mixture contains each of turmeric, astragalus, red sage and ginger, the combination may be referred to as a four-herb mixture, and when combined with the rhubarb-water mixture, as a five-herb mixture. In one preferred embodiment, an herbal composition comprising rhubarb, astragalus, red sage root, turmeric, and dried ginger in accordance with the principles of the present invention is prepared by first preparing a decoction as follows. A measured amount of the five herbs described above should be weighed according to the following proportions: 40.0% rhubarb roots, 26.7% turmeric roots, 13.3% astragalus roots, 13.3% red sage roots, and 6.7% dried ginger roots. The rhubarb roots are then placed in a first stainless steel container with a quantity of clean water approximately 6 to 8 times the weight of the rhubarb roots. Similarly, the other four herbs are placed together in a second stainless steel container with clean water approximately 6 to 8 times the combined weight of the herbs. When 1500 grams total weight of the herb mixture is used, the later for herbs are placed in 5400 ml water. All of the herbs are allowed to soak for 6 to 12 hours, preferably at least 8 hours. The herbal mixture is formed when the herbs and water in the second container are brought to a rolling boil, with constant stirring, and simmered at the boiling temperature for approximately 20 minutes (or until the fluid is reduced by half) to create a four-herb mixture. The cold rhubarb-water mixture in the first container is then added to the contents of the second container to yield a five-herb mixture. The combined mixture is heated to and maintained at about 85 to 95°C, or simmered at a temperature just below the boiling point of the mixture, for approximately 20 minutes with constant stirring. It is important not to heat the five-herb mixture to a boil because boiling removes very important rhubarb volatiles from the solution. The mixture is then allowed to cool to about a warm temperature of between approximately 40 to 50° C. Neither ice nor any other cooling mechanism should be used for the cooling process, however, because the herbs must be allowed to react with each other during the slow cooling period. The resulting decoction exhibits the weight reducing effect of the invention although further processing may be performed to produce a composition in a particular form e.g. a concentrated liquid, powder, etc. or other formulation suited for a particular mode of aό ninistration.

To remove the insoluble, solid components remaining in the solution, the cooled mixture is then filtered and strained by conventional methods, preferably at least twice by using multi-layered medium filter paper, filter press, centrifuge cloth-lined sieve, or cheesecloth. The resulting warm final liquid extract may be-directly administered orally, preferably between meals on an empty stomach for rapid assimilation. In another embodiment, the above final Hquid extract is then condensed into a concentrated liquid extract by evaporation. The concentrated liquid extract may be placed in a rotary evaporation flask and heated at the temperature below 85°C until the extract is condensed to about 1/10 of its original volume. In another preferred embodiment, a conventional freeze-drying process is used to condense the final liquid extract into a powder form. Preferably, the final liquid extract is cooled at -80°C and then placed on a standard laboratory freeze drier overnight to transform the extract into powder form. To create a lyophilizate, 10 mL of extract was quickly frozen in a dry ice/ethanol bath. The sample was freeze-dried for 13 hours, and a very fine powder was obtained. There was no evidence of gums or resins in this mixture. The 10 mL of extract yielded 0.5 g of particulate matter. The powder was dissolved in 0.68 mL of water and the resulting solution was slightly thick and dark brown in color, and yielded a product that is suitable for commercial use. Alternatively, a conventional spray dry process can be used wherein the formulation is expelled through an orifice, typically a nozzle, to produce atomization of the liquid. Due to the increased surface area of the fine droplets, the liquid dries quickly and a substantially homogenous dry mixture is obtained.

Both the final liquid extract and the freeze-dried powder contain a quantity of the herbal mixture with a dry weight in the range of 2 grams to 30 grams. As described above, the resulting herbal liquid or the powder may be incorporated into a pill, tablet or other pharmaceutically acceptable form and may then be taken by patients as one dose with a daily dosage of up to three doses per day in a quantity greater than 6 grams per day. Alternatively, the final liquid extract or powder form is mixed with a food or food supplement such as beverages, energy bars, protein or carbohydrate supplements or powders and other similar edibles. While the total dose administered on a daily basis may vary depending on the clinical indication of the patient or user, the threshold of at least 6 grams per day, preferably at least 12 grams, and up to approximately 30 grams, is important to effect weight loss in humans. For the chronically or severely obese, higher dosages may be administered under the direct supervision of a physician who carefully monitors a patient's entire metabolic and biochemical profile. As a guideline, the total amount given to a patient daily should effect a targeted weight loss goal without causing side effects, such as excessive bowel movement or possible diarrhea. Generally, the maximum daily dosage is such that patients shall not have bowel movement three times more than usual after taking this supplement, hi a clinical setting, the patient's physical reaction may be monitored after taking the first dose to decide whether the second or third dose should be given. The amount of the second or third dose may also be adjusted - accordingly. Alternatively, when the final liquid extract, the concentrated liquid, or the powder form is mixed in foods, the dosage can be altered to reflect the nature of the foods or the patterns of intended consumption ranging from the maximum permitted in the clinical setting described above to smaller dosages for over-the-counter foods or beverages.

Having generally described the present invention, a further understanding may be acquired by reference to the following examples, representing experimental studies conducted to investigate the effects of an herbal formula prepared as a decoction comprising rhubarb, astragalus, red sage root, turmeric, and dried ginger on reduction in weight gain and alteration of body composition of rats, and in clinical trials to demonstrate actual weight loss in humans.

EXAMPLES

Example 1 - Male Sprague-Dawley Rats - 2.5/5.0g dryberbal administration

Male Sprague-Dawley rats were made obese by dietary intervention only. After 180 days, when their average weight reached about 620 grams, they were administered daily by stomach intubation (5mL) either the amount of the decoction DRD extracted from 2.5 grams or 5.0 grams of the dry herbal. Over a 90-day treatment period, the rats administered the 2.5 grams DRD lost about 30% of their pre-treatment body weight, and the fat/lean ratio decreased by 13 fold. The rats administered the 5.0 grams DRD lost about 39% of their pre-treatment weight, and their fat/lean ratio decreased by 25 fold. The metabolic rates of the rats treated with either dose of DRD were restored to normal. The obese controls gained 20 grams and the normal rats gained approximately 103 grams over the 90-day treatment period. The weight loss of the rats receiving the DRD did not appear to have become asymptotic by the end of the 90-day experiment feeding period. Upon administering 5 gram of DRD in the period of 90days, the blood sugar level of the obese rats was reduced by 40%>. The level of triglyceride in the obese rats was reduced by 90%. The level of cholesterol was reduced by approximately 60%. The level ofthe LDL was reduced by 70%. While the level of HDL was increased by 70%. Treatment of the obese rats with the other Hpid lowering drugs in parallel with DRD demonstrated that the Hpid lowering effect of DRD was better than many other Hpid lowering drugs, such as resins, statins, fibrates, and niacin.

Example 2 — Male and Female Wistar rats (hypothalamic lesions) — 2.5/5.0g dry herbal administration

Male and female Wistar rats with hypothalamic lesions were made obese by providing the high caloric diet for 180 days, after which the male rats reached an average weight of about 580 grams and the female rats reached an average weight of about 430 grams. At that time, they received a daily administration of either 2.5 grams DRD or 5.0 grams DRD for 90 days by intubation (5mL).

The male Wistar rats receiving the 2.5 grams DRD and 5.0 grams DRD lost about 36% and 41% of their pre-treatment body weight, respectively. The male obese control rats gained about 10 gram and the male normal control rats gained about 120 grams, (from a mean staring weight of approximately 423 grams), over the 90-day treatment period.

The females lost about 33% and 42% of their pre-treatment body weight when administered the 2.5 and 5.0 grams DRD, respectively. The loss of weight in both genders became asymptotic at about 45 days. The female obese controls maintained a constant weight and the female normal control rats gained about 50 grams (from a mean starting weight of approximately 350 grams) over 90-day treatment period.

Example #3 — Male Wistar rats — 1.0/1.5/5.Og dry herbal administration

Young growing male Wistar rats, of about 220 grams average initial weight, were fed the obesity-inducing diet. Concomitantly, the rats were administered, 1.0 gram DRD, 1.5 grams DRD, or 5.0 grams DRD, by daily intubation, for 90 days. The treatment groups gained 21%, 24% and 47% less weight, respectively, than did the placebo controls. The rats administered fenfluramine gained 22% less weight than did the controls.

Administration of the herbal decoction of the present invention prevented weight gain in a high fat diet and a dose-dependent manner. The data and a morphological examination indicate that the rats that administered the decoction had significantly less parametrial fat than did the controls and slightly higher protein/fat ratios. Thus, the prevention of weight gain appears to be due to a reduction in fat storage, and that the skeletal muscle had been preserved. No significant adverse or side effects were observed in the rats administered the herbal decoction during the experimental period, nor was there any observed during the recovery period.

Example #4 — Female Wistar rats — low/high dose DRD (aqueous extract) 1.0/1.5/5. Og dry herbal adrninistration Sixty female Wistar rats, averaging 220 g in weight, were randomly allotted to five experimental groups and fed the high fat diet described in Table I below for 56 days. The rats were housed individually in wire mesh cages equipped with an automated watering system. The room housing the rats was maintained at a temperature of 22° to 24° C, with a light-dark cycle of 12 hours each. Following the one-week quarantine period the rats were adapted to handling, and to oral insertion of the gastric intubation device over the next ten days. Water was intubated once a day during this period. After ten days, the rats no longer indicated marked distress during the procedure.

TABLE I

"Proctor and Gambel, Cincinnati, OH ^bICN Biomedicals, Aurora, OH

°AIN mineral mix 76, ICM Biomedicals, Costa Mesa, CA ^dAIN vitamin mix 76, ICM Biomedicals, Costa Mesa, CA

After adaption to the intubation procedure, the diet of Table I was initiated. This diet is comprised of 56% of energy from fat. All treatment and placebo intubations occurred between 1600 and 1800 hours. Individual food intake was measured daily throughout the study. Body weight was measured daily through day 23 and twice weekly thereafter. The experimental period lasted 56 days. Lin, X., M.R. Chavex, R.C. Brach, et al., J Nutrition 128:1606-13, 1998.

Referring to Table II below, the five groups consisted of: the control group (n=15), which were fed ad libitum, and were intubated daily with 1 mL of water. The "low dose DRD" (n=10) and the "high dose DRD" (n=15) groups, which were fed ad libitum and administered daily 1 mL of the aqueous extract obtained from 0.75 grams and 1.50 grams of the initial dried herb mixture by intubation, respectively. The "fenfluramine group" (n=10), which was fed ad libitum and received 2 mg/kg fenfluramine in 1 mL of water daily, by intubation, and, finally, a fifth group (n=10) was pair-fed to the high dose DRD group and was administered 1 mL of water daily, by intubation.

TABLE II

Food consumption for all rats was determined daily, and body weights were obtained daily for the first 23 days, and then twice a week for the next 33 days. After 56 days all the rats except five from the control group and five from the high dose DRD group were sacrificed. Trunk blood was collected, and the eviscerated carcasses were homogenized, dried and assayed for body composition. White and brown fat depots, liver, kidney, spleen, heart, and gastrocnemius muscle were weighed. During the 56 days of the experiment, all rats were observed daily by the animal technician, and weekly by a veterinarian, and notations were made regarding physical activity/lethargy, fur condition, skin condition, eye condition, stools, and "others." There were no noticeable differences among any of the groups with regard to physical activity, skin condition, and eye condition. However, initially after intubation, the rats fed the DRD did exhibit some rubbing of the mouth and nose areas. This rubbing resulted in some alopecia. This behavior lasted about one week and then stopped. The other groups did not exhibit this rubbing. The rats administered either dose of DRD had loose stools for the first few days. By the end of the first week the stools of the rats fed the low dose DRD were well formed and the consistency appeared normal. However, after one week the consistency of the stools of the rats fed the high dose DRD generally still appeared softer than the stools of the rats in the other groups. Soft stools were observed among the high dose DRD-treated rats from time to time during the course of the study. Additionally, the stools of both DRD groups were reddish in color, and remained so for the duration of the experiment.

The serum was analyzed for insulin, corticosterone and leptin, using standard commercially available immunoassays for the rat. Alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, chloride, cholesterol, creatinine phosphokinase, γ-glutamyl tianspeptidase, glucose, hemoglobin, hematocrit, mean cell volume, platelets, potassium, sodium, triglycerides, and white blood cells were assayed by standard clinical laboratory methods. All data were pooled by treatment and subjected to a One- Way Analysis of Variance (ANOVA) followed by a Scheffe Comparison of Means analysis (for unbalanced groups). Statistix^® for Windows, 1998. Analytical Software, Tallahassee, FL 32317.

The rats that were not sacrificed and had previously received the high dose DRD had their treatment withdrawn during a 14-day "recovery period." On the 15^th day of this recovery period these rats, plus five control rats, were sacrificed and all the above analyses were conducted.

At time zero, the mean weights of the five animal groups were not different from each other. By the end of the first week the rats treated with fenfluramine had weight gain differences from the controls that would remain very consistent throughout the eight- week study (range from 14.0 to 19.6 grams). During the first half of the study, and especially during weeks two through four, the weight gain differences between the fenfluramine-treated rats and the controls paralleled those of the low dose DRD group. However, the fenfluramine weight gain differences remained constant for the remaining four weeks while the low dose DRD group substantially increased the weight gain difference from controls during this same period. The weight gain differences for the pair-fed rats mimicked those of the rats treated with high dose DRD. From the third to the eighth week the weight gain differences of the pair-fed rats ranged from 34.6 to 46.6 grams.

The data indicate that the high dose DRD treatment exerts an effect on the rats early in the treatment cycle, and that this effect remained fairly constant over the remaining course of the study. The low dose DRD rats exhibit a delay in reaching steady state in weight difference. The DRD may prevent or reduce the deposition of fat (especially in the parametrial region) in the female rat, and when a steady state is reached, this reduction remains constant throughout the study. This would account for the consistent difference in absolute weight, but not consistent differences in percent weight, seen in this study. The maximum effect of fenfluramine in rats, although not as large as that ultimately seen with either DRD group, occurred by the end of the first week.

Referring to Figure 1, the cumulative weight gain for each animal was determined on days 7, 14, 21, 27, 34, 41, 48 and 56 (weeks 1 through 8). At days 7 and 14, average weight gains of the rats in each of the four treatment groups were significantly less than the weight gains of the controls, but not different from each other. Statistically significant separation among the four treated groups did not occur until the 21^st day, but then this pattern was maintained for the remainder of the study. The control group gained the most weight. The weight gains for the group receiving low dose DRD and the group receiving fenfluramine were significantly less than that of the control group, but were not significantly different from each other. The weight gains for the group receiving the high dose DRD (Group 3), and the group being pair-fed to the high dose DRD group, were significantly less than the control group, the low dose DRD group, and the fenfluramine group, but not different from each other.

- On the 56^th day of treatment, the rats administered -low dose DRD and high dose DRD had gained 24.6% and 33.4% less weight respectively than did the control rats. The rats administered fenfluramine gained 12.3% less weight than did the controls. Changes in body weight and weight gain over the eight week experimental period for the treatment groups are shown in TABLE HI, and changes in weight gain are shown in Figure 2.

TABLE in

any of the treatment groups over the 56-day period. The rats administered fenfluramine and low dose DRD consumed less total food over the 56 day period than the co trols, but significantly more food than the rats fed the high dose DRD (and the rats that were pair-fed). The rats fed the high dose DRD and those that were pair fed ate significantly less total food over the 56 day period than did the other groups of rats, but the same as each other.

Weight loss due to decreased food efficiency suggests that a metabolic effect is occurring in the rats. At the end of the 56-day treatment period, the control rats realized significantly greater food efficiency than did any of the treatment groups. Referring to Figure 3, the food efficiencies of rats fed the low dose DRD and the rats fed fenfluramine, when calculated from grams of food ingested, were significantly greater than either the group in which rats were fed the high dose DRD or the group in which the rats were pair-fed. Rats fed the low dose and high dose DRD had food efficiencies that were 15.6% and 22.5% lower than controls, respectively. The food efficiency of the fenfluramine group was 7.8% lower than controls, suggesting a dose-related decrease in food efficiencies. Somewhat anomalously, the pair-fed group, which might be expected to have a higher food efficiency than fenfluramine or DRD-treated groups, had a lower food efficiency similar to that of the high dose DRD group. When food efficiency was calculated as a function of calories ingested, and requirements for basal metabolism were subtracted, differences in food efficiency existed between the groups. Pair-fed rats, fenfluramine rats, and low dose DRD rats exhibited somewhat lower food efficiencies than the controls, and the rats fed the high dose DRD had the lowest food efficiency. These differences between groups, however, did not reach statistical significance, but only reflected a trend (p=0.10).

When food efficiency for the rats was calculated as a function of mean body weight and calories consumed, calories required for maintenance were subtracted from total calories consumed, yielding calories available for gain. Referring to Figure 4, food efficiency may be expressed as the gain in weight for each calorie available for gain above maintenance. Thus, food efficiency for the control group, the fenfluramine-treated group, the pair fed group, and the groups administered low dose DRD, high dose DRD, was 0.0584, 0.0545, 0.0539, 0.0517, and 0.0497 grams respectively, per calorie remaining after the calories required for maintenance had been met.

The rat control group had the highest food efficiency; requiring only 17.09 ingested calories to cause a one-gram gain in weight. This value was obtained by dividing the actual gain per day (2.18 grams) by the daily energy available for gain (37.20 calories). The groups administered low dose DRD and fenfluramine required 18.83 and 18.16 calories to cause a one-gram weight gain respectively, and thus had lower food efficiencies than the control. The group administered the high dose DRD, however, had the lowest food efficiency, requiring 19.35 calories to gain the same one-gram. The pair-fed rats required less calories than did the high dose DRD-treated group to gain the same weight. The amount of calories required by the pair-fed rats, 18.14, is similar to that required by the low dose DRD-treated and fenfluramine- treated rats.

No differences were found between the animal groups for any of the serum indices evaluated after the 56-day experimental period, with the exception of leptin. There is generally a direct positive correlation between the quantity of leptin in the blood and the amount of body fat and an increase in the risk of diabetes mellitus. At the end of the 56-day treatment period, the control rats had significantly more leptin in their blood than did the other treatment groups. The rats administered fenfluramine had less leptin than controls, but significantly more than the rats administered either dose of DRD or the pair-fed rats. The differences in leptin values continued during the 14-day recovery period despite the withdrawal of DRD, but this might be expected due to the modest weight gain seen during that period.

Serum insulin levels reflect the metabolic processes related to carbohydrate and fat storage and usage for energy. Corticosterone is a hormone necessary to combat stress and maintain intermediary metabolism. There were no statistical differences between the serum insulin or corticosterone levels for the controls or any of the treatment groups suggesting that the treatments did not adversely affect the rats' metabolism, nor did they cause stress.

The data demonstrate that the herbal decoction of the invention significantly reduces the rate of weight gain in growing female rats fed a high fat diet when compared to controls. The rats administered the high dose DRD and low dose DRD gained 33.4% and 24.6% less weight, respectively, than did the controls. Further, this weight reduction appears to occur in a dose-dependent manner, as shown in Figure 5. The regression analysis of the computer- generated dose-response curve yields a relationship with a r² value of 0.73 and an r value of 0.85, with a significance of greater than 99%. Increasing the dosage did increase the weight difference effect. However, it appears that a dose of approximately 2.5 g of original plant material equivalent mL is an effective and efficient dose that results in substantial differences in weight between treated and control rats.

Referring to Figure 6A, the weight gain data for the DRD-treated male rats as a percent of control for the animals in Example 3 at 56 days was compared to the weight gain data for the DRD-treated female rats in Example 4 as a percent of control at 56 days. At 56 days the percent weight gain trends of the DRD-treated rats in both studies were similar, but the female rats in Example 4 showed greater differences from controls (gained less weight as a percent of the controls) than did the male rats in Example 3.

However, referring to Figure 6B, when the weight gains as a percent of control weights in Example 4 were compared to later time periods of the study in Example 3, the differences from controls were similar. In Example 3, at 65 days the percent differences between the DRD-treated male rats and the controls reached the level at which they would generally remain for the duration of the 90-day study.

Referring to Figure 7, the weight of all treated groups in Example 4 were compared to the weight of animal controls for weeks one through eight and the differences in absolute weight between the groups were evaluated. The data indicate that the differences in weight between the rats treated with high dose DRD and the controls increased for the first three weeks, and these differences then generally remained consistent (range of 36.9 to 46.5 grams) until the end of the study. The rats treated with low dose DRD maintained a fairly consistent difference in weight from the controls for the first four weeks (range of 11.4 to 18.8 grams). During the fifth week, however, the difference increased, and this increase remained consistent for the remaining four weeks of the study (range of 28.6 to 34.0).

Although the percent total body fat of the rats determined at the end of the study was not significantly different among any of the groups, the amount of parametrial fat in the rats administered high dose DRD was significantly less than any other group of rats. The rats administered low dose DRD and the pair-fed rats had more parametrial fat than did the high dose DRD rats, but significantly less than either the controls or the rats administered fenfluramine. Referring to Figure 8, when body compositions, and respective grams of fat + ash, protein, water, and fat, of 220 gram rats were compared to like indices of the rats after 56 days of treatment, the control rats had gained significantly more weight as fat than did any of the other rats. The rats administered the low dose DRD and the fenfluramine gained significantly less fat than did the controls, and the rats fed the high dose DRD gained the least amount of fat and the differences were significantly different from all other groups. The gain in protein, however, was not different among any of the groups, indicating that the differences in lack of weight gain could be attributed to lack of fat gain but not lack of protein gain.

In conclusion, administration of the DRD herbal decoction significantly slowed the rate of weight gain in rats fed the high fat diets, in a dose-dependent manner. Also, the rats administered the DRD decoction had significantly less parametrial fat than did the controls. Both DRD groups also had higher protein/fat ratios than the pair fed rats and the controls, although not significantly so, indicating that the prevention of weight gain was due to a reduction in fat storage, and that the skeletal muscle had been preserved. The reduction in weight gain experienced by the groups administered DRD also involved a reduction in food ingestion caused by a probable anorectic effect. Rats fed the low dose and high dose DRD had food efficiencies that, when measured as a function of grams of food ingested, were significantly 15.6% and 22.5% lower than controls, respectively, but were not lower than the pair-fed rats. When measured as a function of energy ingested statistical significance was not reached, but a trend (p=0.10) was observed. The control rats had the highest food efficiency (exhibited the greatest gain per calorie remaining after maintenance requirements were met). The pair-fed rats and the rats administered fenfluramine and low dose DRD were grouped together with lower food efficiencies than the controls, and the rats fed the high dose DRD had the lowest food efficiency.

Example 5 — Actual Weight Loss in Humans

The data in Table TV below demonstrate the actual weight loss observed in humans for two dosages of the DRD decoction in clinical trials conducted with the formulation described in the previous examples. Although the data from the rat studies would have suggested that a dosage of 60 g/day would have been required, dosages of about 10% of this value were tested and demonstrated to produce actual weight loss in humans. Specifically, a dose of 20% (12 grams) of the dose that would have been predicted from the rat studies, produces moderate, sustained weight loss in humans. As is apparent from Table IV and Figures 9 and 10, two different, but conventional dehydration processing conditions (freeze dried and spray dried) were tested for production of product at the 6 gram dosage level. To be certain that the observed weight loss is attributed to the DRD decoction, all human clinical subjects consumed similar, monitored diets that provided approximately the same calories per kilogram body weight.

Referring again -to Figures 9 and 10, with this particular formulation of the DRD decoction, 6 grams per day is the approximate "no effect" dose i.e., that dose at which the effect of administration of the composition is indistinguishable from placebo. In this trial, human clinical subjects administered 6 grams per day, regardless of the processing treatment, did not lose any more weight than subjects administered a placebo. Although subjects administered the 6 grams per day dosage did not lose any more weight than those on placebo, a transient weight loss effect was observed with subjects who were administered the 6 gram per day dosage that was dehydrated by a spray dry processing technique. These subjects initially lost more weight than those administered a 6 gram daily dosage of the decoction using a conventional freeze dry dehydration technique. However, the weight loss was not sustained. Given the fact that a transient weight loss was seen at a dosage of 6 grams per day, and the effect described below, wherein a moderate, sustained weight loss was observed at a dosage of 12 grams per day, this formulation is demonstrated to begin producing a measurable weight loss at a dosage exceeding 6 grams per day and the threshold effect occurs at a dosage between 6 grams per day and 12 grams per day.

Subjects who were administered a 12 grams per day daily dosage of the freeze dry decoction lost more weight than subjects who were administered the placebo and exhibited greater weight loss than the subjects administered the 6 gram daily dose regardless of the dehydration processing method used. Based on this data, the 12 gram daily dosage produces a modest, but sustained weight loss in humans. Therefore, in a preferred dosage of the composition of the invention, the subjects are administered a daily dose that is greater than approximately 6 grams per day, may be approximately 12 grams per day or may be any value between approximately 6 and 12 grams per day. The dosage could comprise any value between 6 grams per day and less than 60 grams per day in one embodiment. In one preferred embodiment, the dosage would comprise between approximately 12 grams per day and 30 grams per day. Hi another embodiment, the dosage would be approximately 30 grams per day. The preceding dosages and dose ranges are based on a solid product prepared by a simple dehydration from the liquid decoction prepared in the foregoing examples. Additionally however, it is possible to concentrate the individual components of the liquid decoction, and concentration methods are known that selectively increase the concentration of various effective components of the composition such that the individual and collective concentrations of certain individual components, or groups of components, can be designed to facilitate any particular purpose. Given the ability to concentrate the individual components, or subsets of these components, the ultimate dose may fall between approximately 5 and 20 grams per day with a particularly preferred dosage being approximately 10 grams per day. Of course, if the composition were combined with other carriers or food products, the ratio and weight percentages within a product would vary accordingly. TABLE IV

GROUP 1: FREEZE-DRIED, MAX DOSE = 12 GMS/DAY

Su

GROUP 2: FREEZE-DRIED, MAX DOSE = 6 GMS/DAY (PLUS 6 GMS/DAY PLACEBO)

Su

ofiliϋϋ lil^β iilPβ

GROUP 3: SPRAY DRIED, MAX DOSE = 6 GMS/DAY (PLUS 6 GMS/DAY PLACEBO)

Su

GROUP 4: PLACEBO. DOSE = 12 GMS/DAY

Subject No

DMG/5 AAD/15

DRM/6 KLW/23 MDG/20

There will be various modifications, improvements, and applications of the disclosed invention that will be apparent to those of skill in the art, and the present application encompasses such embodiments to the extent allowed by law. Although the present invention has been described in the context of certain preferred embodiments, the full scope of the invention is not so limited, but is in accord with the scope of the following claims.

Claims

I claim:

1. An herbal composition for effecting weight loss in humans comprising rhubarb, turmeric, astragalus root, red sage root, and ginger root prepared in a liquid decoction and dehydrated to form a dry powder.

2. The herbal composition of claim 1 wherein the dry powder is prepared as a daily dose of at least 6 grams.

3. The herbal composition of claim 1 wherein the dry powder is prepared as a daily dose of less than 60 grams.

4. The herbal composition of claim 1 wherein the dry powder is prepared as a daily dosage of between 5 and 20 grams.

5. The herbal composition of claim 1 wherein the dry powder contains all of turmeric, astragalus root, red safe root, and ginger root and is prepared as a dry powder at a daily dosage of between greater than 6 and less than 60 grams per day.

6. The herbal composition of claim 5 wherein the dosage is between approximately 12 and 30 grams per day.

7. A method of preparing an herbal decoction comprising: soaking rhubarb in water to yield a rhubarb-water mixture; soaking at least one of turmeric, astragalus root, red sage root, and ginger root to yield an herbal mixture; boiling the herbal mixture; adding the rhubarb-water mixture to the herbal mixture, resulting in a rhubarb- herbal mixture; heating the rhubarb-herbal mixture without boiling, allowing the rhubarb-herbal mixture to cool; filtering the cooled rhubarb-herbal mixture to collect the liquid extract; and processing the liquid extract to concentrate the non-aqueous components.

8. The method of claim7 wherein the rhubarb is soaked for at least 6 hours.

9. The method of claim 7 wherein the herbal mixture is boiled for at least 20 minutes.

10. The method of claim 7 wherein the step of adding the rhubarb-water mixture to the herbal mixture is performed while the four-herb mixture is boiling.

11. The method of claim 7 wherein the step of processing the hquid extract is performed by freeze drying the hquid extract to yield a powder form.

12. The method of claim 7 wherein the step of processing the liquid extract is performed by condensing the hquid extract to yield a concentrated fluid.

13. The method of claim 7 further comprising the step of producing a dry powder for administration at a daily dosage of between approximately greater than 6 and less than 60 grams per day.

14. The method of claim 13 wherein the daily dosage is between 12 and 30 grams per day.

15. A method to effect weight loss in humans comprising administering the composition of any of claims 1-14.