A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis.

Phase 2

Recruiting

• Conditions: Osteoarthritis

• Registration Number: CTRI/2012/07/002776
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine.

Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program.

This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country.

**Punarnava Guggulu**, a polyherbal Ayurvedic formulation containing Rakta Punarnava (Boerhaavia diffusa), Eranda (Ricinus communis), Sunthi (Zingiber officinale), Guggulu (Commiphora wightii), Trivrta (Ipomoea turpethum), Danti (Baliospermum montanum), Guduci (Tinospora cordifolia), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Marica (Piper nigrum), Pippali (Piper longum), Saindhava, Citraka (Plumbago zeylanica), Bhallataka (Semicarpus anacardium), Vidanga (Embelia ribes) and Bhasma of Makshika dhatu.

**Dashmoola Ghrita** is medicated fatty preparation containing Bilva (Aegle marmelos), Syonaka (Oroxylum indicum), Gambhari (Gmelina arborea), Patala (Stereospermum suaveolens), Agnimantha (Premna integrifolia), Salaparni (Desmodium gangeticum), Prsniparni (Uraria picta), Brhati (Solanum indicum), Kantakari (Solanum xanthocarpum), Goksura (Tribulus terrestris), Puskara (Inula racemosa), Sati (Hedychium spicatum), Bilva (Aegle marmelos), Tulasi (Ocimum sanctum), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Hingu (Ferula foetida) and Ghrita.

**Kottamacukkadi Taila** is an oil preparation containing Kustha (Saussurea lappa), Sunthi (Zingiber officinale), Vaca (Acorus calamus), Sigru (Moringa oleifera), Lasuna (Allium sativum), Himsra (Capparis spinosa), Devdaru (Cedrus deodara), Sarsapa (Brassica campestris), Rasna (Alpinia galanga), Tila (Sesamum indicum), Dadhi (curd of cow’s milk) and Cinca (Tamarindus indica).

The present study entitled **“Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamacukkadi Taila in the Management of Osteoarthritisâ€** is being undertaken in three peripheral institutes of the CCRAS. The same is in the process of being registered **(Reg No. -****CTRI/2012/02/002416****)** in the Clinical Trials Registry, India (CTRI) as an activity under the ACT project.

The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale) 2.
• Pain in the affected joint(s) > six weeks.
• Willing and able to participate in the study.

Exclusion Criteria

• History of any surgical /diagnostic intervention with reference to the affected joint(s).
• Patients who are incapacitated, bedridden or confined to a wheelchair.
• Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis 4.
• Patients having any deformity of knee, hip or back.
• Patients with poorly controlled Hypertension ( >160/100 mm of Hg) 6.
• Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr.
• PP) >200 mg% or HbA1c> 6.5%}.
• Patients with evidence of malignancy.
• Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
• or any other drugs that may have an influence on the outcome of the study.
• Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
• Symptomatic patients with clinical evidence of Heart failure.
• Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
• Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
• Alcoholics and/or drug abusers.
• H/o hypersensitivity to any of the trial drugs or their ingredients.
• Pregnant / lactating woman.
• Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in WOMAC total score	At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC stiffness Domain Score	At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
Change in WOMAC Physical function Domain	At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
Change in Patient’s Global Assessment of the Disease Activity Scale	At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks

Trial Locations

Locations (3)

Ayurveda Central Research Institute (ACRI), New Delhi; 🇮🇳 West, DELHI, India

National Research Institute for Panchakarma (NRIP), Cheruthuruthy; 🇮🇳 Thrissur, KERALA, India

North Eastern India Ayurveda Research Institute (NEIARI), Guwahati; 🇮🇳 Kamrup, ASSAM, India

Ayurveda Central Research Institute (ACRI), New Delhi

🇮🇳West, DELHI, India

Dr H Panigrahi

Principal investigator

9968074400

drhemanta@sify.com