PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Fri, 11 Jan :23:08 GMT) CTRI Number Last Modified On 23/04/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 10/05/2012] - Trial Registered Retrospectively Yes Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the treatment of Urinary stone. Clinical Evaluation of Palashaa Kshara and Pashanbheda Kwatha Churna in the Management of Urolithiasis 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 Central Council for Research in Ayurvedic Sciences (CCRAS), Details Contact Person (Scientific Query) Central Council for Research in Ayurvedic Sciences (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 Details of Ethics Committee Central Council for Research in Ayurvedic Sciences (CCRAS), Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), Jaipur. 2. Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola. 3. Tilak Ayurved Mahavidyalaya, Pune. Type of Sponsor List of Countries of Principal Investigator Dr MK Shringi Dr Sanjiv Kr Tripathi Dr Anil Sharma Dr Bihari Rai Dr Ramesh Gangal Dr Kunal Pravinsinh Patil Primary Sponsor Details AYUSH Ministry of Health Family Welfare Government 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), Jaipur Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola Tilak Ayurved Mahavidyalaya, Pune Shalyatantra, Amer Road, Madhav Vilas Palace, Jaipur Jaipur RAJASTHAN Shalyatantra, Paprola, District Kangra Kangra HIMACHAL PRADESH Shalyatantra, 583/2, Rasta Peth, Pune Pune MAHARASHTRA m m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Approved 09/11/2010 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Committee, National Institute of Ayurveda (NIA), Jaipur Institutional Ethics Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola Institutional Ethics Committee, Tilak Ayurved Mahavidyalaya, Pune Status Health Type Patients Approved 15/03/2011 No Approved 07/09/2010 No Date No Date Specified Condition Urolithiasis Type Details Intervention Palashaa Kshara along with Pashanbheda Kwath Churna Comparator Agent Not applicable Not applicable Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria PALASHAA KSHARA-Dose-One tablets (500 mg) twice daily; Dosage form- Tablets; Route of Administration-Oral; Time of Administration-Twice a day after food; Anupana- Water ;Packing form-plastic jar containing 30 hard gelatin capsules of 500 mg each; and Duration of therapy-12 weeks Along With PASHANBHEDA KWATHA CHURNA-Dose- 25 gm twice daily; Dosage form-kwath churna (Coarse powder for decoction); Route of Administration-Oral; Time of Administration-Twice a day before food; Anupana- Water; Packing form- Plastic jar containing 30 sachets of 25 gm each; and Duration of therapy-12 weeks. 1. Patients of either sex aged years 2. Radiological / Ultrasonological evidence of single calculus / multiple calculi 3. Willing and able to participate for 16 weeks Exclusion Criteria 1. Urinary Tract Infection (UTI) 2. Patients with obstructive uropathy 3. Patients with known metabolic/endocrinal disorder favouring calculus formation. 4. Patients with evidence of malignancy. page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking 5. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%). 6. Patients suffering from major systemic illness necessitating long term drug.treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 7. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 8. Symptomatic patients with clinical evidence of Heart failure. 9. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 10. 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. 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). 12. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease or any other condition that may jeopardize the study. 13. Alcoholics and/or drug abusers. 14. H/o hypersensitivity to any of the trial drugs or their ingredients. 15. Patients who have completed participation in any other clinical trial during the past six (06) months. 16. Pregnant or lactating woman. 17. Any other condition which the Principal Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Expulsion of calculus Change in Size of calculus 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 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) Symptomatic improvement Change in quality of life (SF-36 Heath Survey Score) Total Sample Size=150 Sample Size from =150 01/03/2011 No Date Specified Years=1 Months=6 Days=0 Symptomatic improvement assessment 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 Heath Survey Score assessment at Baseline, at 84th day and after completion of follow up at the end of 16 weeks. page 4 / 5

5 Powered by TCPDF ( PDF of Trial Recruitment Status of Trial () Publication Details Brief Summary 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. Palashaa Kshara is a white alkaline preparation prepared from the plant called Palash (Butea monosperma). Pashanbheda Kwatha Churna is the powder of the dried of rhizomes of the plant called Pashanbheda (Bergenia ciliata). 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 Palashaa Kshara and Pashanbheda Kwatha Churna- the classical Ayurvedic formulations which have been in use since ages and found to be useful in treating Urolithiasis 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