Clinical Trial Details (PDF Generation Date :- Fri, 17 Aug 2018 19:15:52 GMT) CTRI Number Last Modified On 23/03/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/002524 [Registered on: 27/03/2012] - Trial Registered Retrospectively No Interventional Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the treatment of Anaemia. Clinical Evaluation of Punarnavadi Mandura and Dadimadi Ghrita in the Management of Iron Deficiency Anaemia 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
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. Central Research Institute (ACRI), Jaipur. 2. National Institute of Pharmaceutical Research (NIAPR), Patiala. 3. National Research Institute of Ayurvedic Drug Development (NRIADD), Bhubaneswar Type of Sponsor List of Countries of Principal Investigator Dr H M L Meena Dr Rajesh Sannd Dr Banmali Das Primary Sponsor Details Central Council for Research in Ayurvedic Sciences CCRAS, New Delhi-, INDIA Research institution of Site Site Phone/Fax/ Central Research Institute (ACRI), Jaipur National Institute of Pharmaceutical Research (NIAPR), Patiala National Research Institute of Ayurvedic Drug Development (NRIADD), Central 9785297017 Research Institute M. S. 0141-2282618 Central Research hari_mohan68@yahoo. Institute (Ay.), Indira co.in Colony, Bani Park, Jhotwara Road, Jaipur-302016 Jaipur RAJASTHAN National Institute of Pharmaceutical Research (NIAPR), Moti Bagh Road, Patiala-147001 Patiala PUNJAB 9501295077 0175-2228361 sanndrajesh@yahoo.co m National Research 9439956684 Institute of Ayurvedic 0674-2530125 Drug Development, Unit vdbdas@yahoo.co.in No.1, page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Bhubaneswar Bhubaneswar-751009 Khordha ORISSA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, NIAPR, Patiala, Punjab. Committee, ACRI, Jaipur. Committee, NRIADD, Bhubaneswar. Status Health Type Patients Approved 19/03/2011 No Approved 20/04/2011 No Approved 21/04/2011 No Date No Date Specified Condition Iron Deficiency Anaemia Type Details Comparator Agent Intervention Age From Age To Gender Details Punarnavadi Mandura along with Dadimadi Ghrita. 15.00 Year(s) 60.00 Year(s) Both Inclusion Criteria PUNARNAVADI MANDURA-Dose 500 mg twice daily; Dosage form - tablet of 250 mg; Route of Administration oral;time of Administration-Twice a day before food; Anupana-Lukewarm Water;Packing form-plastic jar containg 60 tablets;duration of therapy-12 weeks AND DADIMADI GHRITA -Dose 10 gm twice daily; Dosage form - Ghrita Route of Administration Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water/Milk Packing form-300 gm pet jar Duration of therapy-12 weeks 1) Patients of either sex aged between 15 to 60 years. 2) Patients with iron deficiency anaemia (Hb 8gm-10gm.%), 3) Patients with peripheral blood smear suggestive of Iron deficiency Anaemia 4) Willing and able to participate for 14 weeks. Exclusion Criteria Details 1. Patients suffering from Thalassemia major / Aplastic anaemia / Sickle cell anaemia. 2. Patients with evidence of malignancy. 3. Patients suffering from major systemic illness necessitating long page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding disorders, etc.) 4. 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. 5. Symptomatic patient with clinical evidence of Heart failure. 6. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 7. Patients suffering from Diabetes Mellitus {B.S. (F) > 250 mg/dl. 8. Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 9. 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), Total Serum Cholesterol & / or Serum Triglycerides > 250 mg/dl, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]). 10. Alcoholics and/or drug abusers. 11. Pregnant / lactating woman 12 H/o hypersensitivity to the trial drug or any of its ingredients. 13 Patients who have completed participation in any other clinical trial during the past six (06) months. 14 Any other condition which the Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Change in Hb% At Baseline, 14-28-42-56-70-84 days and at the end of 14 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 _ Symptomatic relief. _ Change in Serum ferritin level. _ Change in Peripheral Blood Smear Picture. Total Sample Size=150 Sample Size from =150 19/07/2011 No Date Specified Years=1 Months=0 Days=0 Symptomatic relief at Baseline, 14-28-42-56-70-84 days and at the end of 14 weeks. Serum Ferritin and Peripheral Blood Smear at Baseline, day 42 and day 84. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial (Global) 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 The is an autonomous body under the Department of AYUSH (, 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 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 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 colleges across the country. Punarnavadi Mandura, is a classical polyherbal Ayurvedic formulation containing Punarnava (Boerhaavia diffusa), Trivrta (Ipomoea turpethum), Shunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Vidanga (Embelia ribes), Devdaru (Cedrus deodara), Citraka (Plumbago zeylanica), Kushtha (Saussurea lappa), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellirica), Amalki (Emblica officinalis), Danti (Baliospermum montanum), Cavya (Piper chaba), Indrayava (Holarrhena antidysenterica), Musta (Cyperus rotundus), Mandura Bhasma (Calcined Mandura), Gomutra (Cow urine). Dadimadi Ghrita is a medicated ghrita containing Dadima (Punica granatum), Dhanyaka (Coriandrum sativum), Citraka (Plumbago zeylanica), Shunthi (Zingiber officinale), Pippali (Piper longum) and Ghrita. The present study entitled Clinical Evaluation of Punarnavadi Mandura and Dadimadi Ghrita in the Management of Iron Deficiency Anaemia is being undertaken in three peripheral institutes of the CCRAS. Similar study going on as PG Thesis work in three Colleges has been registered (Reg No. CTRI/2012/01/002335) with the Clinical Trials Registry, (CTRI) as an activity under the Clinical Trials (ACT) project. The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. page 5 / 5