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1 Clinical Trial Details (PDF Generation Date :- Sat, 01 Dec :40:54 GMT) CTRI Number Last Modified On 02/02/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/02/ [Registered on: 13/02/2012] - Trial Registered Retrospectively Yes Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulation in the management of arthritis. Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamacukkadi Taila in the Management of Osteoarthritis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Details Contact Person (Scientific Query) Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), Jaipur. 2. Tilak Ayurved Mahavidyalaya, Pune. 3. Vaidyaratnam P. S. Varier Ayurved College, Kottakkal, Kerala. Type of Sponsor List of Countries of Principal Investigator Prof Ajay Kumar Sharma Dr Jyothi Kanwar Dr RS Huparikar Dr Amit Chavan Dr CV Jayadevan Dr Gaurav Munjal Primary Sponsor Details Department of AYUSH Ministry of Health and Family Welfare Government of Department of AYUSH, Ministry of Health & Family Welfare, Government of, IRCS Building, Red Cross Road, New Delhi Government funding agency of Site Site Phone/Fax/ National Institute of Ayurveda (NIA) Tilak Ayurved Mahavidyalaya, Pune Office of the Director and the Department of Kayachikitsa, Amer Road, Madhav Vilas Palace, Jaipur Jaipur RAJASTHAN Department of Panchakarma, 583/2, Rasta Peth, Pune , Maharashtra, Pune MAHARASHTRA Vaidyaratnam P. S. Department of Varier Ayurved College, Panchakarma, Kottakkal Kottakkal, P.O. Edarikode, Mallapuram Malappuram KERALA ajay_sharma_54@hotm ail.com ayurvedapune@gmail.c om drcvjd@gmail.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, National Institute of Ayurveda (NIA), Jaipur Committee, Tilak Ayurved Mahavidyalaya, Pune Committee, VPSV Ayurved College, Kottakkal Status Health Type Patients Approved 09/11/2010 No Approved 07/09/2010 No Approved 15/10/2010 No Date No Date Specified Condition Osteoarthritis Type Details Intervention Punarnava Guggulu Dose 1 gm (2 Tablets) twice daily Dosage form - Tablet of 500 mg Route of Administration oral Time of Administration-Twice a day after food Anupana-Lukewarm Water Packing form- Jar containg 60 tablet Duration of therapy-12 Intervention Dashmoola Ghrita Dose 10 gm twice daily Dosage form - Ghrita Route of Administration Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-300 gm pet jar Duration of therapy-12 Intervention Kottamachukadi Tailam Dose 20 ml twice daily Dosage form - Oil Route of Administration Local application Time of Administration-Twice a day Packing form-300 ml plastic bottle Duration of therapy-12 Comparator Agent Not applicable Not applicable Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Patients of either sex aged between 40 and 75 years. 2. Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale) 3. Pain in the affected joint(s) > six. 4. Willing and able to participate in the study. page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Exclusion Criteria 1. History of any surgical /diagnostic intervention with reference to the affected joint(s). 2. Patients who are incapacitated, bedridden or confined to a wheelchair. 3. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis 4. Patients having any deformity of knee, hip or back. 5. 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%}. 7. Patients with evidence of malignancy. 8. Patients on prolonged (> 6 ) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 9. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 10. Symptomatic patients with clinical evidence of Heart failure. 11. 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. 12. Alcoholics and/or drug abusers. 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Pregnant / lactating woman. 15. Patients who have completed participation in any other clinical trial during the past six (06) months. 16. Any other condition which the Principal Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints 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 16. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Change in WOMAC stiffness Domain Score Change in WOMAC Physical function Domain Change in Patient s Global Assessment of the Disease Activity Scale Total Sample Size=150 Sample Size from =150 01/12/2010 At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16. page 4 / 5

5 Powered by TCPDF ( PDF of Trial Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified Years=1 Months=6 Days=0 Open to Recruitment To be published after completion of the clinical trials in all the three centers. Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate 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). Punarnava Guggulu, Dashmoola Ghrita and Kottamachukadi Tailam have been in use since ages and found to be useful in the management Osteoarthritis and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis. The is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. page 5 / 5