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1 Clinical Trial Details (PDF Generation Date :- Mon, 04 Dec :39:47 GMT) CTRI Number Last Modified On 29/03/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/ [Registered on: 30/03/2012] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in patients suffering from Menopause related problems. Clinical Evaluation of Ashokarishta, Ashwagandha Churna and Pravala Pishti in the Management of Menopausal Syndrome. 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 contraceptive Drug Research Institute (ACDRI), Ahmedabad. 2. Ayurveda Mental Health Research Institute (AMHRI), Nagpur. 3. Ayurveda Research Institute for Mother and Child Health Care (ARIMCHC), Type of Sponsor List of Countries of Principal Investigator Dr Rinku Tomar Dr Savita Sharma Dr Indira Kumari Primary Sponsor Details Central Council for Research in Ayurvedic Sciences CCRAS, New Delhi-, INDIA Research institution of Site Site Phone/Fax/ Ayurveda contraceptive Drug Research Institute (ACDRI), Ahmedabad Ayurveda Mental Health Research Institute (AMHRI), Nagpur Ayurveda Research Institute for Mother and Child Health Care (ARIMCHC), Ayurveda contraceptive Drug Research Institute, Block 0/3, Mental Hospital Campus, Meghaninagar, Ahmedabad-16 Ahmadabad GUJARAT Ayurveda Mental Health Research Institute, Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan. Nagpur Nagpur MAHARASHTRA Ayurveda Research Institute for Mother and Child Health Care, Poojapura, ail.com com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria KERALA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, ACDRI, Ahmedabad. Committee, AMHRI, Nagpur. Committee, ARIMCHC,. Status Health Type Patients Approved 19/04/2011 No Approved 23/03/2011 No Approved 24/03/2011 No Date No Date Specified Condition Menopausal Syndrome Type Details Comparator Agent Intervention Age From Age To Gender Details Ashokarishta and Ashwagandha Churna along with Pravala Pishti Year(s) Year(s) Female Inclusion Criteria 1. Females of age between 40 and 55 years ASHOKARISHTA Dose 25 ml twice daily;dosage form Arishta (Fermented liquid); Route of Administration oral;time of Administration-Twice a day after food; Anupana-Water in equal quantity;packing form- 400 ml pet Bottle;Duration of therapy-12 weeks Along with ASHWAGANDHA CHURNA Dose 3gm twice daily; Dosage form Sachet of 3 gm each; Route of Administration oral; Time of Administration-Twice a day ½ an hour before food; Anupana-Milk; Packing form- Plastic Jar containing 30 sachets; Duration of therapy-12 weeks And PRAVALA PISHTI Dose 1 capsule (250 mg) twice daily; Dosage form Capsule of 250 mg; Route of Administration Oral; Time of Administration- Twice a day ½ an hour before food; Anupana-Milk; Packing form-plastic jar containing 30 capsules; Duration of therapy-12 weeks. page 3 / 5

4 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details 2. Amenorrhoea for more than or equal to 12 months 3. Kupperman menopausal index score more than or equal to FSH more than or equal to 20 IU/L 5. Thickness of endometrium less than or equal to 5 mm 6. Willing and able to participate for 14 weeks Exclusion Criteria 1. Patients with evidence of malignancy 2. Surgical menopause 3. Established cases of any mental illness 4. Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250 mg/dl) 5. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 6. 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. 7. Symptomatic patients with clinical evidence of Heart failure. 8. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 9. Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, hormone replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. 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). 11. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease, Hypothyroidism 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. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Change in the clinical symptoms (using Menopause Rating Scale). At Baseline, Day and at the end of 14 weeks. Secondary Outcome Outcome Timepoints??Change in level of Serum Estradiol.??Change in Leutinising Hormone??Change in level of Follicular Stimulating At Baseline and at Day 84 (Quality of Life assessment done at the end of 14 weeks also). page 4 / 5

5 Powered by TCPDF ( REF/2012/03/ Hormone??Change in quality of Life by using Menopause Specific Quality of Life Questionnare (MENQOL). 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 07/06/2011 No Date Specified Years=1 Months=0 Days=0 Open to Recruitment To be published after the completion of 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. Ashokarishta is a fermented liquid Ayurvedic formulation containing Ashoka (Saraca asoca), Dhataki (Woodfordia fruticosa), Jiraka (Cuminum cyminum), Musta (Cyperus rotundus), Shunthi (Zingiber officinale), Daruharidra (Berberis aristata), Utpala (Nymphaea stellata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Amrasthi (Mangifera indica), Jiraka (Cuminum cyminum), Vasa (Adhota vasica), Chandana Sveta (Santalum album) and Guda. Ashwagandha Churna is containing air dried mature root of Withania somnifera. Pravala Pishti is consisting of air dried powder of praval bhasma with the help of Rose water. The present study entitled Clinical Evaluation of Ashokarishta, Ashwagandha Churna and Pravala Pishti in the Management of Menopausal Syndrome is being undertaken in three peripheral institutes of the CCRAS. The cumulative evidence generated as an activity under the ACT project as well as the IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. page 5 / 5