Clinical Trial Details (PDF Generation Date :- Mon, 03 Dec 2018 14:24:00 GMT) CTRI Number Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/04/002584 [Registered on: 18/04/2012] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial A clinical study to see the effect of an Ayurvedic formulation in the patients suffering from Breathlessness. Clinical Evaluation of Vyaghri Haritaki in the Management of Bronchial Asthma 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. Ayurveda Central Research Institute (ACRI), Jaipur 2. Ayurveda Mental Health Research Institute (AMHRI), Nagpur 3. National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada Type of Sponsor List of Countries of Principal Investigator Dr B R Meena Dr M N Suryavanshi DrGK Swamy Primary Sponsor Details Central Council for Research in Ayurvedic Sciences CCRAS, New Delhi- Research institution of Site Site Phone/Fax/ Ayurveda Central Research Institute (ACRI), Jaipur Ayurveda Mental Health Research Institute (AMHRI), Nagpur National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada Ayurveda Central Research Institute, Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016 Jaipur RAJASTHAN Ayurveda Mental Health Research Institute, Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur-440009 Nagpur MAHARASHTRA National Ayurveda Research Institute for Vector Borne Diseases, Indira Gandhi Municipal Stadium Complex A, 9414320438 0141-2282618 meenabaniram@yahoo. com 9403119332 0712-2714230 vmsuryawanshi@yahoo.co.in 9989350323 0866-2472535 swamykowshik@yahoo. com page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria First Floor, North Wing Vijayawada-520010 Krishna ANDHRA PRADESH of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, ACRI, Jaipur Committee, AMHRI, Nagpur. Committee, NARIVBD, Vijayawada, Andhra Pradesh,. Status Health Type Patients Approved 20/04/2011 No Approved 23/03/2011 No Approved 21/04/2011 No Date No Date Specified Condition Bronchial Asthma Type Details Comparator Agent Intervention Vyaghri Haritaki Dose-10 gm twice daily Dosage form-avaleha Route of Administration-Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-300 gm jar Duration of therapy-12 weeks Age From Age To Gender Details Details 18.00 Year(s) 60.00 Year(s) Both Inclusion Criteria 1. Patients of either sex with age between 18 to 60 years. 2. Patient with stable Bronchial Asthma for at least 6 weeks prior to study entry. 3. Positive test of reversibility: Symptomatic patients - an improvement of 60 L/min or?20% in PEFR, 10 minutes after the inhalation of 200 mcg of Salbutamol. Asymptomatic patients - 60 L/min or?20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200 mcg of Salbutamol, when assessed after 10 minutes. 4. Patient willing and able to participate for 16 weeks. Exclusion Criteria 1. Patients with PEFR 2. Patients with evidence of malignancy. 3. Patient with poorly controlled Diabetes Mellitus (HbA1c > 10%). 4. Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic? 100 mm of Hg) 5. Patients on prolonged (? 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 6. 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, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 7. Patients who have a past history of Atrial Fibrillation, 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 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), Severe Pulmonary Dysfunction, or any other condition that may jeopardize the study. 10. Smoker/alcoholics and/or drug abusers. 11. H/o hypersensitivity to the trial drug or any of its ingredients. 12. Patients who have completed participation in any other clinical trial during the past six (06) months. 13. Pregnancy or lactating women. 14. Any other condition which the Principal Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Change in the clinical symptoms (Asthma Control Questionnaire). Baseline, At the end of 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up period of 4 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 () Publication Details Brief Summary Change in St George s Respiratory Questionnaire (SGRQ-C). Change in the objective parameters of PEFR & FEV1. Total Sample Size=150 Sample Size from =150 21/07/2011 No Date Specified Years=1 Months=0 Days=0 Open to Recruitment Baseline, at the end of 84th day and at the end of follow up period of 4 weeks To be published after completion of the clinical trial in all the three centers. Baseline, At the end of 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up period of 4 weeks. 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 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. Vyaghri Haritaki is a polyherbal Ayurvedic formulation containing Kantakari (Soalnum surratense), Haritaki (Terminalia chebula), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Tvaka (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Ela (Elettaria cardamomum), Nagkesara (Mesua ferrea), Jaggery and Honey. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial The present study entitled Clinical Evaluation of Vyaghri Haritaki in the Management of Bronchial Asthma is being undertaken in three peripheral institutes of the CCRAS. The same has been registered (Reg No.- CTRI/2011/12/002276 ) in the Clinical Trials Registry, (CTRI) as an activity under the 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 this classical Ayurvedic formulation. page 5 / 5