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1 Clinical Trial Details (PDF Generation Date :- Tue, 23 Oct :34:35 GMT) CTRI Number Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 06/07/2012] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis. Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamachukadi Tailam 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 (CCRAS), Details Contact Person (Scientific Query) (CCRAS), 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 (CCRAS), Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. Ayurveda Central Research Institute (ACRI), New Delhi 2. North Eastern Ayurveda Research Institute (NEIARI), Guwahati 3. National Research Institute for Panchakarma (NRIP), Cheruthuruthy Type of Sponsor List of Countries of Principal Investigator Dr H Panigrahi Dr P K S Nair Dr T Borah Primary Sponsor Details Central Council for Research in Ayurvedic Sciences CCRAS, New Delhi-, INDIA Research institution of Site Site Phone/Fax/ Ayurveda Central Research Institute (ACRI), New Delhi National Research Institute for Panchakarma (NRIP), Cheruthuruthy North Eastern Ayurveda Research Institute (NEIARI), Guwahati Ayurveda Central Research Institute, Road No.66, Punjabi Bagh, New Delhi National Research Institute for Panchakarma, Cheruthuruthy, Via-Shoranur, Distt.-Trichur, Pin Thrissur KERALA North Eastern Ayurveda Research Institute, Borsojai (Bhetapara), Beltola, Guwahati drhemanta@sify.com dr_pksnair@yahoo.co.i n t.borah09@rediffmail.co m page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Kamrup ASSAM of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, ACRI, New Delhi. Committee, NEIARI, Guwahati. Committee, NRIP, Cheruthuruthy. Status Health Type Patients Approved 03/05/2011 No Approved 24/03/2011 No Approved 12/04/2011 No Date No Date Specified Condition Osteoarthritis Type Details Comparator Agent 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 Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria 1. Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale) 2. Pain in the affected joint(s) > six. 3. Willing and able to participate in the study. Exclusion Criteria 1. History of any surgical /diagnostic intervention with reference to page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking 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 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First 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 15/06/2011 No Date Specified page 4 / 5

5 Powered by TCPDF ( PDF of Trial Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=1 Months=0 Days=0 Open to Recruitment To be published after the completion of the clinical trials in all the three centers. The is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of. CCRAS is an apex body in 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 Osteoarthritis 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, (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. page 5 / 5