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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :40:37 GMT) CTRI Number Last Modified On 08/05/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 18/05/2012] - Trial Registered Retrospectively Yes Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the management of Rheumatoid Arthritis. Clinical Evaluation of Simhanaada Guggulu and Brihata Saindhavadi Taila in the Management of Rheumatoid Arthritis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details of Principal Investigator, (CCRAS), West Details Contact Person (Scientific Query), (CCRAS), Details Contact Person (Public Query) Details Contact Person (Public Query) page 1 / 5

2 , (CCRAS), Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar. 2. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi. 3. Government Ayurveda College, Thiruvananthapuram Type of Sponsor List of Countries of Principal Investigator Dr G Vinodkumar Dr Aji K S Dr A R Dave Dr Pravin Kharadi DrNiranjan Rao DrVishwanath Wasedar Primary Sponsor Details Department of AYUSH Ministry of Health 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/ Government Ayurveda College, Thiruvananthapuram Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi Department of Panchakarma, Thiruvan anthapuram drgvinodkumar@yahoo. Thiruvananthapuram com KERALA Department of Kayachikitsa, Gujarat Ayurved University,Jam nagar Jamnagar GUJARAT alankruta@yahoo.com Department of Panchakarma, P.O Kuthpady, niranjanrao_a@rediffm Laxminarayana Nagara, ail.com Udupi Udupi KARNATAKA of Committee Approval Status Date of Approval Is Independent Ethics Committee? page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee, Govt. Ayurveda College, Thiruvananthapuram, Kerala, Committee, IPGT&RA, Jamnagar, Gujarat, Committee, SDM College of Ayurveda, Udupi, Karnataka, Status Health Type Patients Approved 06/09/2010 No Approved 09/07/2010 No Approved 13/07/2010 No Date No Date Specified Condition Rheumatoid Arthritis Type Details Intervention Simhanaada Guggulu and Brihata Saindhavadi Taila Comparator Agent Not applicable Not applicable Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria SIMHANAADA GUGGULU:Dose 1.5 gm (3 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- Bottle containg 60 tablets;duration of therapy-12 weeks; And BRIHATA SAINDHAVADI TAILA: 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 weeks. 1) Patients of either sex with age between 20 and 60 years 2) Presence of any four out of the following seven criteria (according to 1987, revised criteria of American College of Rheumatology) a. Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 week s duration). b. Arthritis of three or more joints, at least three joint area, observed by Physician, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration). c. Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration). d. Symmetric arthritis (more than 6 week s duration). e. Presence of rheumatoid Nodules f. Serum rheumatoid factor- positive g. Typical radiographic changes of arthritis on PA view of hand & page 3 / 5

4 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details wrist radiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints. 3) PATIENTS Willing and able to participate in the study for 16 weeks. Exclusion Criteria 1. Patients who have developed complications of Rheumatoid Arthritis e.g. deformity of joints / bones, pleura-pericardial disease, or else. 2. Patients who are unable to walk without support and / or confined to wheel chair. 3. Patients with structural deformity as the complication of RA. 4. Patients with poorly controlled Hypertension ( >160/100 mm of Hg) 5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% OR HbA1c> 6.5%} 6. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc. 7. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. Symptomatic patients with clinical evidence of Heart failure. 10. 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. 11. Alcoholics and/or drug abusers. 12. H/o hypersensitivity to any of the trial drugs or their ingredients. 13. Pregnant / lactating woman. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Principal Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Changes in DAS-28 score At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. Secondary Outcome Outcome Timepoints Change in Disability Index (The n Health Assessment Questionnaire) Change in acute phase reactants ESR and CRP At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. SF-36 is assessed at Baseline, 84th day and at page 4 / 5

5 Powered by TCPDF ( Change in Health Questionnaire SF-36 the end of follow up after 16 weeks. Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=150 Sample Size from =150 10/01/2011 No Date Specified Years=1 Months=6 Days=0 Open to Recruitment To be published after the 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. Simhanaada Guggulu is a polyherbal Ayurvedic formulation containing Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Gandhaka (Sulphur), Guggulu (Commiphora wightii) and Eranda (Ricinus communis). Brihata Saindhavadi Taila is a medicated classical Ayurvedic oil preparation contain Saindhava lavana (Rock salt), Gajapippali (Scindapsus officinalis), Rasana (Alpinia galanga), Satpuspa (Anethum sowa), Yavani (Trachyspermum ammi), Svarjiksara (Crude alkaline earth), Marica (Piper nigrum), Kustha (Saussurea lappa), Sunthi (Zingiber officinale), Saurvancala Lavana (Black salt), Vida Lavana, Vaca (Acorus calamus), Ajmoda (Apium leptophyllum), Yashtimadhu (Glycyrrhiza glabra), Sveta Jiraka (Cuminum cyminum), Puskara (Inula racemosa), Pippali (Piper longum), Eranda Taila (Ricinus communis), Satapuspajambu (Anethum sowa), Kanjika (Sour gruel) and Mastu (Curd whey from cow milk). The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of Simhanaada Guggulu and Brihata Saindhavadi Taila- classical Ayurvedic formulation which have been in use since ages and found to be useful in treating Rheumatoid Arthritis and promoting the health. 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