PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar :37:21 GMT) CTRI Number Last Modified On 28/03/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/03/ [Registered on: 31/03/2015] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial A clinical study to see the effects of Ayurvedic Formulation in Apparently Healthy Elderly Persons. Evaluation of Clinical Efficacy and Safety of Brahma Rasayana 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 Contact Person (Public Query) Details of Principal Investigator Dr Rohit Kumar Ravte Phone Fax Research Officer (Ay.) (Scientist -2) Principal Investigator Institute of Ayurvedic Drug Development under CCRAS Institute of Ayurvedic Drug Development 4 CN Block, Sector-V, Bidhannagar, WEST BENGAL rohitkravte@rediffmail.com Details Contact Person (Scientific Query) Dr Pradeep Dua Phone Fax Research Officer (Ay.) Nodal Officer Central Council for Research in Ayurvedic Sciences (CCRAS) CCRAS Deptt. Of AYUSH, Ministry of Health & Family Welfare, Govt. of , Institutional Area, Opp. D Block, Janakpuri, New Delhi West DELHI duadrpradeep@gmail.com Details Contact Person (Public Query) Dr Pradeep Dua Research Officer (Ay.) Nodal Officer Central Council for Research in Ayurvedic Sciences (CCRAS) CCRAS Deptt. Of AYUSH, Ministry of Health & Family Welfare, Govt. of , Institutional Area, Opp. D Block, Janakpuri, New Delhi West DELHI 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 Phone Fax Source of Monetary or Material Support > National Ayurveda Dietetics Research Institute, Government Central Pharmacy Annexxe, Ashoka Pillar, Jayanagar, Bangalore > Institute of Ayurveda Drug Development, Bhubaneswar > Institute of Ayurvedic Drug Development, 4CN Block, Sector V, Bidhannagar, Type of Sponsor List of Countries of Principal Investigator Primary Sponsor Details CCRAS New Delhi Central Council for Research in Ayurvedic Sciences (CCRAS), Deptt. Of AYUSH, Ministry of Health & Family Welfare, Govt. of. Jawahar Lal Nehru, Bhartiya Chikitsa Eveam Homoeopathy Anusandhan Bhawan No , Institutional Area, Opp. D Block, Janakpuri, New Delhi Research institution Dr Banamali Das Out Patients division Bhubaneswar Dr G Venkateshwarlu Dr Rohit Kumar Ravte of Site Site Phone/Fax/ Out Patients division Bangalore Out Patients division kolkata Institute of Ayurveda Drug Development, Bhubaneswar Khordha ORISSA banamali.d@gmail.com National Ayurveda Dietetics Research Institute, Government drvenkatg@gmail.com Central Pharmacy Annexxe, Ashoka Pillar, Jayanagar Bangalore Bangalore KARNATAKA Institute of Ayurvedic Drug Development 4 CN Block, Sector-V, Bidhannagar, WEST BENGAL rohitkravte@rediffmail.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee of Human Research (IEC-HR) of Institute of Ayurvedic Approved 06/12/2012 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Drug Development, Committee, National Ayurveda Dietetics Research Institute, Bangalor Committee, National Research Institute of Ayurvedic Drug Development, Bhubaneswar Status Health Type Healthy Human Volunteers Approved 05/11/2012 No Approved 12/12/2012 No Date No Date Specified Condition Elderly persons Type Details Intervention Brahma Rasayan Drug : Brahma Rasayan Dose : 15 g BD Route of Administration : Oral Anupana : Luke warm milk Duration of Therapy : 12 Weeks Study Design Level of study : OPD level only Type of study : Interventional Purpose : Geriatric care Masking : Open lebel Control : Not Control Group : Single Follow-up period :14 days. Comparator Agent Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details Criteria for Inclusion : 1.Apparently Healthy Male/ Female on clinical examination of age between years. 2.Patients complaining of general weakness and other vague complaints not including the involvement of any particular system. 3.Willing to participate Exclusion Criteria 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 disorder 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.Uncontrolled Hypertensive (taking more than two drugs) 6.Patients on Prolonged (>6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcomes of the study. 7.Patients with concurrent serious hepatic disorder (defined as page 3 / 5

4 Aspatate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit or Renal Disorder (defined as S. Creatinine > 1.2 mg/dl). 8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD), Inflammatory Bowel Disease, Serve Dementia, Severe Infection(s), Non-ambulatory patients or nay other condition that may jeopardize the study. 9.Prostate Specific Antigen (PSA) level >4 ng/ml. 10.Alcoholics and/ or drugs abusers. 11.Pregnant/ lactating women s 12.Patients suffering from uncontrolled Diabetes {HbAlc>9%) 13.HIV positive subjects. 14.H/o hypersensitivity to the trial drug or any of its ingredients. 15.Patients who have complete participation in nay other clinical trial during the past (06) months. 16.Any other condition which the Investigator thinks may jeopardize the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints 1. Change in Clinical Symptom (using the visual analogue scale) 2. Change in Quality of Life using WHOQOL-BREF 1. At base line 14th days, 28th days, 42nd days, 56th days, 70th days and end of the 84th days. 2. At base line 28th days, 56th days and end of the 84th days. Secondary Outcome Outcome Timepoints Secondary outcome measures : 1. At base line 28th days, 56th days at the end of 1. Change in Hamiliton Depression Rating Scale 84th days. (HAM-D) 2. At base line 28th days, 56th days at the end of 2. Change in PGI Memory Scale 84th days. 3. Change in the Laboratory parameter like ESR, 3. At base line end of 84th days. Serum cholesterol, HDL, LDL, CRP, TSH, Serum Vitamin D3, Serum Ca. 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 Total Sample Size=180 Sample Size from =180 01/03/2013 No Date Specified Years=1 Months=0 Days=0 Closed to Recruitment of Participants To be published after the completion of the clinical trials in all the three centers. page 4 / 5

5 Powered by TCPDF ( Brief Summary The Central Council for Research in Ayurvedic Sciences (CCRAS) 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 classical Ayurvedic formulations, multicentric clinical trials have been initiated in peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) programme. BRAHMA RASAYANA is a poly-herbal preparation containing : Haritaki, Amalaki, Bilva, Syonaka, Gambhari, Patala, Agnimantha, Salaparni, Prsniparni, Brhati, Kantakari, Goksura, Bala, Rakta Punarnava, Eranda, Masaparni, Mudgaparni, Satavari, Meda, Jivanti, Jivaka, Rsabhaka, Sali, Kasa, Sara, Darbha, Iksu, Water for decoction reduced to, Tvak, Suksmaila, Musta, Haridra, Pippali, Agaru, Sveta Candana, Mandukaparni, Nagakesara, Sankhapuspi, Vaca, Kaivartamusta, Yasti, Vidanga, Sitopala, Ghrta, Tila, Madhu. The present study entitled "Evaluation of Clinical Efficacy and Safety of Brahma Rasayana in Apparently Healthy Elderly Persons" is being undertaken in three peripheral Institute of CCRAS. The comulative evidence generated as an activity under the IMR Programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these Classical Ayurvedic Formulations. page 5 / 5