Clinical Trial Details (PDF Generation Date :- Tue, 25 Dec 2018 01:08:22 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/2012/05/002654 [Registered on: 16/05/2012] - Trial Registered Retrospectively Yes Interventional Ayurveda Single Arm Trial A clinical study to see the Rasayana effect of an Ayurvedic formulation in the Elderly. Clinical Evaluation of Rasayana Effect of Ashwagandhadi Lehya in Apparently Healthy Elderly Persons. 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, Central Council for Research in Ayurvedic Sciences (CCRAS), West Details Contact Person (Scientific Query), Central Council for Research in Ayurvedic Sciences (CCRAS), Details Contact Person (Public Query) Details Contact Person (Public Query) page 1 / 5
, Central Council for Research in Ayurvedic Sciences (CCRAS), Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study 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. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan. Type of Sponsor List of Countries of Principal Investigator Prof Narainsingh Chundawat Dr Mamta Dr Rajika Gupta Dr Sangeeta Verma Dr B Narayana Prakash Dr Savitha H P 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-110001. Government funding agency of Site Site Phone/Fax/ National Institute of Ayurveda (NIA), Jaipur Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan Swasthavruta, Amer Road, Madhav Vilas Palace, Jaipur-302002, Rajasthan, Jaipur RAJASTHAN Swasthavruta, Paprola, District Kangra-176115, Himachal Pradesh, Kangra HIMACHAL PRADESH Kayachikitsa, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201, Karnataka, Hassan 9461624248 0141-2635709 nschundawat.nia@gmai l.com 9418080245 01894242064 rajikadr@rediffmail.com 9902614737 08172-256464 drnpmanas@gmail.com page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria KARNATAKA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, National Institute of Ayurveda (NIA), Jaipur Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola Committee, SDM College of Ayurveda, Hassan, Karnataka, Status Health Type Healthy Human Volunteers Approved 09/11/2010 No Approved 15/03/2011 No Approved 06/01/2011 No Date No Date Specified Condition Apparently Healthy Elderly Persons Type Details Intervention Ashwagandhadi Lehya Dose 10 gm twice daily Dosage form - Avleha Route of Administration oral Time of Administration-Twice a day after food Anupana-Lukewarm Water Packing form- 300 gm pet jar Duration of therapy-12 weeks Comparator Agent Not applicable Not applicable Age From Age To Gender 50.00 Year(s) 75.00 Year(s) Both Inclusion Criteria Details 1. Apparently Healthy Males / Females of age between 50 and 75 years 2. Willing and able to participate for 16 weeks Details Exclusion Criteria 1. Patients with evidence of malignancy 2. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 3. 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. 4. Symptomatic patient with clinical evidence of Heart failure. 5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6. 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. 7. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL). 8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patient or any other condition that may jeopardize the study. 9. Prostate Specific Antigen (PSA) levels > 4 ng/ml 10. Alcoholics and/or drug abusers. 11. Pregnant / lactating woman 12 Patients suffering from Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c > 6.5%}. 13 H/o hypersensitivity to the trial drug or any of its ingredients. 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 Change in the clinical symptoms (using the Visual Analogue Scale). Change in Quality of life using WHO-QOL-BREF At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. WHO-QOL-BREF is assessed only at Baseline, 84th day and at the end of follow up after 16 weeks. 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) Recruitment Status of Trial () Change in Hamilton Depression Rating Scale Score Change in PGI Memory Scale Change in the Laboratory parameters (markers for ageing). o ESR o IL-6 o Serum Cortisol o Serum Cholesterol o High Density Lipoprotein (HDLc) o Low Density Lipoprotein (LDLc) o hs CRP o TSH Total Sample Size=150 Sample Size from =150 20/01/2011 No Date Specified Years=1 Months=6 Days=0 Open to Recruitment At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. The laboratory parameters are assessed at Baseline and on 84th day. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Publication Details Brief Summary To be published after the completion of the clinical trials on 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. Ashwagandhadi Lehya is a poly herbal formulation containing Ashwagandha (Withania somnifera), Sariva (Hemidesmus indicus), Jiraka (Cuminum cyminum), Madhusnuhi (Smilax glabra), Draksha (Vitis vinifera), Sukshma ela (Elettaria cardamomum), Honey, Goghrita and Sharkara (Sugar). 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 Ashwagandhadi Lehya- a classical Ayurvedic formulation which has been in use since ages, and has been found to be useful in 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. Similar clinical trial, being carried out as an Intra Mural Research (IMR) activity by CCRAS in its peripheral institutes has been registered with the Clinical Trials Registry, CTRI/2012/03/002535. The collective evidence generated during the A.C.T. project as well as the I.M.R. program would scientifically substantiate the Rasayana effect of the Ashwagandhadi Lehya. page 5 / 5