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CTRI Number  CTRI/2011/11/002142 [Registered on: 17/11/2011] Trial Registered Retrospectively
Last Modified On: 02/11/2011
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effect of an Ayurvedic formulation in the patients of Bronchitis. 
Scientific Title of Study   Clinical Evaluation of Vyaghri Haritaki in the Management of Chronic Bronchitis. 
Trial Acronym  ACT-BTS-2010 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Source of Monetary or Material Support  
Support in terms of infrastructural facilities: 1. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA),Gujarat Ayurved University,Jamnagar-361001, Gujarat, India 2. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, P.O. – Kuthpady, Laxminarayana Nagara, Udupi-574118, Karnataka, India. 3. Government Ayurveda College, Thiruvananthapuram-695001, Kerala, India. 
 
Primary Sponsor  
Name  Department of AYUSH Ministry of Health Family Welfare Government of India 
Address  Department of AYUSH, Ministry of Health & Family Welfare, Government of India, IRCS Building, Red Cross Road, New Delhi-110001. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof M S Baghel Dr Jaiprakash B Ram  1. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA)  Director-IPGT&RA,Gujarat Ayurved University,Jamnagar-361001, Gujarat, India.
Jamnagar
GUJARAT 		 9427207964
02882676856
baghelayu@rediffmail.com 
DrGShrinivas Acharaya DrNishanth Pai K  2. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi.  Department of Kayachikitsa,SDM College of Ayurveda, P.O. – Kuthpady, Laxminarayana Nagara, Udupi-574118, Karnataka, India.
Udupi
KARNATAKA 		 9448353813
08202533970
gsa.ayurved@gmail.com 
Dr P B Najuma Dr Rajesh prasad   3. Government Ayurveda College, Thiruvananthapuram  Department of Kayachikitsa,Thiruvananthapuram-695001, Kerala, India.
Thiruvananthapuram
KERALA 		 9446359630
04712473656
asokgwai04@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Govt. Ayurveda College, Thiruvananthapuram, Kerala, India  Approved 
Institutional Ethics Committee, IPGT&RA, Jamnagar, Gujarat, India  Approved 
Institutional Ethics Committee, SDM College of Ayurveda, Udupi, Karnataka, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
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  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged between 16 to 70 years.
2. Patients with history of uncomplicated Chronic Bronchitis. (Chronic Bronchitis is defined as a cough that occurs every day with sputum production that lasts for at least three months, two years in a row).
3. Patient willing and able to participate in the study for 16 weeks.
 
 
ExclusionCriteria 
Details  1. Patients suffering from Acute Bronchitis.
2. Patients having PEFR < 50% of the predicted value.
3. Presence of other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.
4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
5. Patients with poorly controlled Hypertension ( ≥160 / 100 mm Hg)

6. Patients on prolonged (> 6 weeks) medication with corticosteroids, bronchodilators, Mast cell stabilizers, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
7. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
9. Symptomatic patients with clinical evidence of Heart failure.
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. Smokers/alcoholics and/or drug abusers.
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. Pregnant or lactating women.
15. Any other condition which the Principal Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the clinical symptoms of chronic bronchitis viz: Productive cough, Dyspnoea, Wheezing, Chest pain, Sore throat and Nasal congestion.  Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in St. George’s Respiratory Questionnaire (SGRQ) scores  Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 4 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/01/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published after the completion of the clinical trials in all the three centers. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.

 Vyaghri Haritaki, a polyherbal Ayurvedic formulation containing Kantakari (Soalnum surratense), Haritaki (Terminalia chebula), Shunthi (Zingiber officinale), Maricha (Piper nigrum), Pippali (Piper longum), Tvaka (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Ela (Elettaria cardamomum), Nagkesara (Mesua ferrea), Jaggery and Honey has been in use since ages, and has been found to be useful in treating Chronic Bronchitis and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of this Ayurvedic formulation as a part of their Post Graduate (PG) Thesis.

The Central Council for Research in Ayurvedic Sciences (CCRAS) 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.

The present study is being undertaken to scientifically study and validate the clinical efficacy and safety of Vyaghri Haritaki- a classical Ayurvedic formulation. This formulation has been in use since ages, and has been found to be useful in treating Chronic Bronchitis and promoting the health. 

 
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