Title of Invention

"A HERBAL FORMULATION FOR THE MANAGEMENT OF OSTEO-ARTHRITIS AND A PROCESS FOR THE PREPARATION THEREOF"

Abstract

This invention relates to a herbal formulation and a process for preparation thereof wherein the herbal formulation is useful for the management of osteo-arthritis. The herbal composition comprises mixture of organic extracts of Commiphore mukul ( guggula), Terminalia arjuna (arjun) Convolvulus pluricaulis (Shankhapushpi), with or without additive. The process for preparation of the formulation comprises mixing of the organic extracts of the above herbs with or without addition of additives.

Full Text

FIELP OF INVENTION This invention relates to a herbal formulation and a process for preparation thereof for the management of Osteo-arthritis to prevent the future complications particularly surgical interventions. The present preparation may also be advantageously used for reduction of pain, restoration of functional capability and reduction of inflammation among the cases showing clinical and radiographic evidences of osteo-arthritis. BACKGROUND OF THE 1NVENITON Osteo-arthritis (OA) is not a single disease rather it is the end result of a variety of problems of joint failure. This clinical condition is characterized by degeneration of particular cartilage and proliferation of new bone, cartilage and connective tissue. Males and females both are affected but Oateo arthritis is more common and severe in older women. As regard the aetiology and pathogenesis of OA is concerned, the abnormal surface contacts, weight-bearing alignments, metabolic diseases, genetically determined defect of homogentistic acid oxidase results in the accumulation of a pigmented polymer that binds to collagen rendering it brittle and prone to mechanical degradation. Crystal deposition of calcium pyrophosphate dihydrate may alter the properties of cartilage matrix directly and low-grade crystal inflammation may play a part in pathogenesis. Pain is at first intermittent and aching is provoked by the use of the joint and relieved by rest. As the disease progresses, movement in the affected joint becomes limited because of pain, muscular spasm, capsular fibrosis, osteophyte formation and remodeling of bone. Muscular wasting is an important factor in the progress of the disease. Although the pathological changes in OA are irreversible but efforts have been made to alleviate symptoms particularly in the early stages. Corticosteroids, hydrotherapy, knee arthroplasty, arthrodesis are advised for its management but due to hazardous side effects such therapies have restrictions. Thus there is an urgent need of safe and useful remedial measure for the management of OA. OBJECT OF THE PRESENT INVENTION An object of this invention is to propose a herbal formulation and process for preparation thereof useful for the management of osteo-arthritis by over-coming the symptoms like pain, inflammation, stiffness, muscular spasm, muscular wasting etc. Another object of this invention is to propose a herbal formulation and process for preparation thereof useful for the management of osteo-arthritis which provides relief to pain and restores functional capability to minimize the risk of slipping. Further object of this invention is to propose a herbal formulation and process for preparation thereof useful for the management of osteo-arthritis to check the rapid formation of capsular fibrosis and osteophyte formation. Still further object of this invention is to propose a herbal formulation and process for preparation thereof useful for the management of anxiety and depression associated with cases suffering with cases suffering from osteo-arthritis. Yet further object of this invention is to propose a herbal formulation and process for preparation thereof to compensate the calcium requirement which is commonly deficient in osteo-cases. DESCRIPTION OF INVENTION According to this invention there is provided a herbal formulation for the treatment of Osteo-arthritis cases comprising. Organic extract of Commiphora mukul (guggulu) 200-500mg Organic extract of Terminalia Arjuna (Arjun) 250-500mg Organic extract of convolvulus pluricaulis 200-500mg with or without known additives. In accordance with a preferred embodiment but without and implying any limitation the ratio of the constituents varies from 4:5:6 to 1:1:1, with or without an additive like calcium sulphate. Further according to this invention there is provided a process for the preparation of a herbal preparation for the management of Osteo-arthritis comprising in admixing: Oganic extract of Commiphora mukul (Guggulu) 200-500mg Organic extract of Terminalia Arjuna (Arjun) 250-500mg Organic extract of Convolvulus pluricaulis (Shankhpushpi) 200-500mg with or without known additive. It is to be understood that the composition of the present invention is not a mere admixture with aggregation of properties but the different ingredients have synergetic effect on each other as none of the individual herb is effective for management of the osteo-arthritis. The chemicals extracted out of the plants are used in the following dose range in a particular manner. 200-500mg Commiphora mukul 250-500mg Terminalia arjuna 300-500mg Convolvulus pluricaulis The drugs are administered with varying dose schedule and a careful monitoring of the clinical symptomatology present different results. On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of: Commiphorn inukul 250 - 250mg Tcrminaliaarjuiia 300 - 400mg Convolvulus pluricaulis 300 - 400mg The remainder is optionally known additive to make the required preparation. Commiphora mukul (Guggulu): This plant commonly known as "Guggulu" belonging to family "Cucurbitaceae" whose dried Gum resin are extracted to collect the mixture of a number of steroids in the form of guggulsterone Z & E and guggulusterol I, II & III. Various studies have shown this mixture possessing potent anti-inflammatory, hypolipidemic anti-obesity properties useful in the management of Osteo-arthric symptoms. Terminalia arjuna (Arjun): This plant commonly known as "Arjun" belongs to the family "Combretaceae". The dried stem bark of the plant is extracted to collect the mixture of saponine and arjunoglucoside I 85 II. Various studies have shown that these compositions have potential effect on the regulation of abnormal lipid metabolism. It supplement the calcium deficiency as it contains small amount of calcium. Convolvulus pluricaulis (Shankhapushpi): This plant is commonly known as 'Shankhpushpi' belonging to family "Convolvulaceae" whose dried whole plant are extracted to collect the mixture of sankhapushpine and steroids. Studies conducted have proven that the leaves and flowers are having anti-anxiety anti hypertensive property and it also improves the mental function. The known additives are excipients such as calcium sulphate. Example-1: The preparation containing the organic extract of Commiphora mukul in the dose of 400 'mg continuously for three months to the subjects suffering from osteo-arthritis exhibited reduction in pain and mild decrease in body mass index. Example-2: The preparation containing the organic extract of Terminalia -arjuna in the dose 350 mg continuously for three months exhibited reduction in body weight by decreasing total body fat and total cholesterol it also provided supplement of calcium to the cases of Oteo-arthritis. Example-3: The preparation containing the organic extract of Convolvulus pluricaulis in the dose of " 350- mg continuously for three months it showed anti-stress and anti-anxiety property. A general feeling of well being was noticed among cases suffering from Osteo arthritis. Example -4: The preparation containing the organic extract of Commiphora mukul in the dose of 300mg and the organic extract of Terminalia arjuna in the dose of 250mg continuously for three months to the cases showing evidence of Osteo arthritis exhibited reduction in inflammation causing better mobility of the joints and reduction in pain. It also reduced the total lipid contents among those Osteo arthritis cases suffering from obesity and hyperlipidema. Example- 5: The preparation containing the organic extract of Commiphoral mukul in the dose of 300 , mg and organic extract of Convolvulus pluricaulis in the dose of 250 , mg continuously for three months exerted its effects in reducing anxiety and stress including its anti-inflammatory and pain reducing properties. Example-6: The preparation containing the organic extract of Terminalia arjuna in the dose of 350 mg and organic extract of convolvulus pluricaulis in the dose of 300 " mg continuously for three months exhibited effect on cholesterol, including mild calcium supplementation and feeling of well being to osteo arthritis cases. Example-7: The preparation containing the organic extract of Commiphora mukul in the dose of 300mg, Terminalia arjuna in the dose of 350 mg and convolvulus pluricaulis in the dose of 250mg continuously for three months exhibited its affectivity in more effective manner. The new preparation improved mobility of the joints and reduction in pain. It also showed effect in reducing stiffness and swelling of the joints. Regulation of abnormal lipid profile was recorded in osteo arthritics cases. Stress related complaints like sleeplessness, irritability early fatigue were also improved. In this invention where the organic extract of Commiphora mukul, terminalia arjuna and Convolvulus pluricaulis is used to prepare a new formulation for the management of symptoms associated with Osteo-arthritis showed 70-80 percent better effectivity than the single herbal drug therapy. Commiphora mukul has anti-inflammatory as well as hypocholesterolemic property. U reduces the pain, improves the joint mobility, and also reduces the body weight and thus reduces the weight wearing joint pain. Terminalia arjuna is more specific for reduction of total cholesterol. Convolvulus pluricaulis acts as an anti stress agent and if mixed along with above two drug it helps in the management of psychological symptoms of Oesteoarthritic patients. Therefore a combine therapy produces better results in comparison to single drug treatment. The herbal composition is a mixture of the organic extract of Commiphora mukul (guggula), Terminan'a arjuna (aijun) and Convolvulus pluricaulis (shankhapushpi) in prescribed doses. In the above formulation the organic extract of Commiphora mukul in a particular proportion given in the patent application showed significant reduction in body weight and cholesterol. It also reduces the arthritic pain. The formulation is only effective if the organic constituent of all the above three plants are mixed in the mentioned doses as described herein. All the tree drugs have a synergetic effect and none of the organic extract given in terms of mg is indicative of weight. Each of the biologically active ingredient was extracted by using alcohol solvent. The termperature was maintained at 69"F. For adding additive calcium sulphate has been use. 1 CLAIM: 1. A herbal formulation for the treatment of Osteo-arthritis cases comprising: Organic extract of Commiphora mukul (guggulu) 200-500mg Organic extract of Terminalia Arjuna (Arjun) 250-500mg Organic extract of convolvulus pluricaulis 200-500mg with or without known additives. 2. A preparation as claimed in claim 1 comprising: Commiphora mukul 250-350mg Terminalia Arjuna 300-400mg Convolvulus pluricaulis 300-400mg with known additive for a preparation of 300mg/500mg. 3. A preparation as claimed in claim 1 comprising an organic extract of Commiphora mukul containing mixture of guggulsterone Z & E and guggulsterol I, II & II. 4. A preparation as claimed in claim 1 wherein the organic extract of Terminalia Arjuna contains arjunic acid and arjunoglucoside 11 & 111. 5. A preparation as claimed in claim 1 wherein the organic extract of convolvulus pluricaulis contains sankhpushpine. 6. A herbal preparation for the management of osteo-arthris substantially described as herein and exemplified in the examples. 7. A process for the preparation of a herbal preparation for the management of Osteo-arthritis comprising in admixing: Organic extract of Commiphora mukul (Guggulu) 200-500mg Organic extract of Terminalia Arjuna (Arjun) 250-500mg Organic extract of Convolvulus pluricaulis 200-500mg (Shankhpushpi) with or without known additive. 8. A process as claimed in claim 7 comprising: Commiphora mukul 250-3 50mg Terminalia arjuna 300-400mg Convolvulus pluricaulis 300-400mg with known additive for a preparation of 300mg/500mg. 9. A process as claimed in claim 7 comprising the organic extract of commiphora mukul containing a mixture of guggulsterone compounds. 10. A process as claimed in claim 7 wherein the organic extract of Terminalia arjuna contain the mixture of arjunic-acid and arjuno-glucosides II & III. 11. A process as claimed in claim 7 wherein the organic extract of convolvulus pluricaulis contains the mixture of sankhapushpine. 12. A process for the preparation of a herbal preparation of the management of Osteo- arthritis as herein described and exemplified in the examples.

Documents:

713-del-2002-abstract.pdf

713-del-2002-claims.pdf

713-del-2002-correspondence-others.pdf

713-del-2002-correspondence-po.pdf

713-del-2002-description (complete).pdf

713-del-2002-form-1.pdf

713-del-2002-form-18.pdf

713-del-2002-form-2.pdf

713-del-2002-form-3.pdf

713-del-2002-form-4.pdf

713-del-2002-form-5.pdf

713-del-2002-gpa.pdf

713-del-2002-petition-others.pdf