Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-07-16
2002-09-17
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S528000
Reexamination Certificate
active
06451355
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is generally directed to compositions and methods for treating diabetes mellitus.
2. Description of the Prior Art
Diabetes mellitus is a disorder of carbohydrate metabolism resulting from insufficient production of or reduced sensitivity to insulin. In persons who have diabetes, the normal ability of body cells to use glucose is inhibited, thereby increasing blood sugar levels. As more glucose accumulates in the blood, excess levels of sugar are excreted in the urine. Corresponding symptoms of diabetes include increased urinary volume and frequency, thirst, itching, hunger, weight loss, and weakness.
There are three variations of diabetes. Type I is insulin-dependent diabetes mellitus for which insulin injection is required. In this type, insulin is not secreted by the pancreas and must be taken by injection. Type II, non-insulin-dependent diabetes mellitus may be controlled by dietary restriction. It derives from sluggish pancreatic secreted insulin. Type III diabetes is caused by the body rejecting the insulin secreted by the pancreas.
Treatment aimed at controlling diabetes involves placing patients on restrictive diets designed to help them reach and maintain normal body weight and to limit their intake of carbohydrates and fats. Diabetics who are unable to produce insulin in their bodies receive regular injections of insulin. Insulin derived from the pancreatic extract of pigs, sheep, and oxen has been used for many years for this purpose. More recently, recombinant DNA technology has made synthetic human insulin available.
Complications from diabetes typically involve the cardiovascular system which accounts for the majority of diabetes-related deaths. Other serious complications include a condition known as diabetic retinopathy (retinal changes leading to blindness), kidney disease, and frequent infection.
Medications have also been employed to help maintain blood glucose levels within target ranges. These medications improve the body's ability to use insulin and decrease the production of glucose by the liver. An example of this type of medication is troglitazone, which is supplied under the name Rezulin® by Parke-Davis. However, troglitazone has been taken off the market by the USFDA because of reported liver injury caused by its use. Other medications often cause nausea when used.
There remains a need for a treatment that will improve the body's ability to use insulin and decrease the production of glucose released by the liver without adverse health effects.
SUMMARY OF THE INVENTION
The present invention is directed to a composition for treating diabetes. The composition includes an effective amount of fenugreek and an effective amount of bile from the gallbladder of a ruminant. The bile and fenugreek powder is mixed together to form a paste from which pills are formed.
The present invention is also directed to a method for treating diabetes. The method involves administering periodic doses of a composition including an effective amount of fenugreek and an effective amount of bile from the gallbladder of a ruminant. The treatment method of the present invention minimizes the complications from diabetes and helps to reverse many of its chronic side effects.
These and other advantages of the present invention will be clarified in the description of the preferred embodiment taken together with the attached drawings in which like reference numerals represent like elements throughout.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The composition for treating diabetes of the present invention includes fenugreek and bile from the gallbladder of ruminants, such as cattle, sheep, bison, and goats. Bile from the gallbladder of cattle is preferred. The fenugreek is preferably pulverized into a powder. The bile and fenugreek is mixed together to form an acceptable medium for administering a dose. This acceptable medium can be a solution, a syrup, an emulsion, a dispersion, a paste, or a pill. It is preferred that a small amount of water be added to the mixture of fenugreek and bile to aid in the formation of pills. Pills are the preferred medium for administering the dose.
Alternatively, the active components of fenugreek can be made synthetically and be formulated into the composition of the present invention. Fenugreek, also spelled foenugreek, is a slender annual herb of the pea family. Its dried seeds have been used for generations as a food, a flavoring, and a medicine. Steroidal saponins account for many of the beneficial effects of fenugreek, particularly the inhibition of cholesterol absorption and synthesis. The seeds are rich in dietary fiber, which may be the reason it can lower blood sugar levels in diabetics.
It is contemplated, as part of the present invention, that fennel seed can be used to replace all or part of the fenugreek in the composition for treating diabetes of the present invention. Fennel seed, like fenugreek, is an herb native to southern Europe and the Mediterranean area.
The second primary component of the present invention is bile from the gallbladder of ruminant mammals. Synthetic compositions of the active components in bile can also be used in the composition of the present invention. Bile, also called gall, is a for concentration, storage, or transport into the first region of the small intestine, the duodenum. Bile is composed of bile acids and salts, cholesterol, pigments, water, and electrolyte chemicals that keep the total solution slightly acidic. The pH of bile is typically about 5 to 6. Bile acid typically includes cholic, deoxycholic, chenodeoxycholic, and lithocholic acids. The bile salts include the salts of these acids with amino acids, such as glycine and taurine. Other components of bile include hemoglobin, mucus, serum proteins, lecithin, neutral fats, fatty acids, and urea.
The method of treating diabetes of the present invention begins with the preparation of doses of a composition for treating diabetes which includes an effective amount of fenugreek and/or fennel seed mixed together with an effective amount of bile from the gallbladder of ruminant mammals. The doses are often mixed together in a paste to form pills. The doses are administered at regular intervals throughout the day. By administered, what is meant is providing the composition to a patient and the patient consuming the composition by accepted medical practice. Accepted medical practice is meant to include any method approved by the American Medical Association for introduction of the composition into the human body.
The amount of the composition administered as part of the doses is an amount sufficient to counteract the effects of diabetes. These effects or symptoms which are affected will include blood glucose levels, stomach neuropathy, appetite, sleep habits, general energy level, strength, body weight, reflux, headaches, Minear's disease, and eye sight. A sufficient amount is an amount, when administered, that provides relief from one or more of the effects or symptoms.
When the composition is administered in the form of a pill, it is preferred that the pills be used with approximate dimensions of 0.5 inches diameter and 0.125 inches thickness. The preferred dose administration is three pills administered three times during the day.
REFERENCES:
patent: 5847109 (1998-12-01), Garti et al.
patent: 6060465 (2000-05-01), Miljkovic et al.
Sharma et al.: Effect of Fenugreek Seed on Blood Glucose and Serum Lipids in Type 1 Diabetes; 1990, Euro. J. of Clinical Nutri., vol. 44, pp. 301-306.
Patten Patricia
Webb Ziesenheim & Logsdon Orkin & Hanson, P.C.
Weber Jon P.
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