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CTRI Number  CTRI/2016/04/006801 [Registered on: 05/04/2016] Trial Registered Retrospectively
Last Modified On: 11/06/2015
Post Graduate Thesis  No 
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 some Ayurvedic formulations in the management of Bronchial Asthma 
Scientific Title of Study   Clinical evaluation of Kanakasava and Trivrit Churna in the management of Bronchial Asthma (Tamaka Swasa) in the management of Bronchial Asthma (Tamaka Swasa) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Kumara Swamy 
Designation  Assistant Director in charge 
Affiliation  National Ayurveda Research Institute for Vector Borne Diseases(CCRAS) 
Address  National Ayurveda Research Institute for Vector Borne Diseases New Rajivnagar Payakapuram Vijayawada Krishna(Dt)Andhra pradesh India

Krishna
ANDHRA PRADESH
520015
India 
Phone  8500064848  
Fax  08662402144  
Email  drrkswami@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr R Kumara Swamy 
Designation  Assistant Director in charge 
Affiliation  National Ayurveda Research Institute for Vector Borne Diseases(CCRAS) 
Address  National Ayurveda Research Institute for Vector Borne Diseases New Rajivnagar Payakapuram Vijayawada Krishna(Dt)Andhra pradesh India

Krishna
ANDHRA PRADESH
520015
India 
Phone  8500064848  
Fax  08662402144  
Email  drrkswami@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr R Kumara Swamy 
Designation  Assistant Director in charge 
Affiliation  National Ayurveda Research Institute for Vector Borne Diseases(CCRAS) 
Address  National Ayurveda Research Institute for Vector Borne Diseases New Rajivnagar Payakapuram Vijayawada Krishna(Dt)Andhra pradesh India

Krishna
ANDHRA PRADESH
520015
India 
Phone  8500064848  
Fax  08662402144  
Email  drrkswami@yahoo.co.in  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences JLNBCAH Anusandhan Bhawan 61-65, OPP D Block Institutional Area, Janakpuri - 110058 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  JLNBCAH Anusandhan Bhavan 61-65, Institutional Area, Opp.D Block, Janakpuri,New Delhi - 110058 
Type of Sponsor  Research institution 
 
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 
DR ANU BHATNAGAR  M.S.Ayurveda Central Research Institute  Room No 25, First floor, Indira colony,Bani Park, Jhotwara Road, Jaipur-302016
Jaipur
RAJASTHAN 		 09261606061
01412282618
anubhatnagar@ymail.com 
DrShashidhar H Doddamani  National Ayurveda Dietetics Research Institute  OPD 1, First floor, Govt.Central Pharmacy Annexe,Ashoka pillar, Jayanagar, Bangalore-560011
Bangalore
KARNATAKA 		 9448085818
08026562030
shd_ayu@yahoo.co.in 
Dr R Kumara Swamy  National Ayurveda Research Institute for Vector Borne Diseases  Room No 207, Second floor, New Rajeev Nagar, Payakapuram, Vijayawada Krishna ANDHRA PRADESH
Krishna
ANDHRA PRADESH 		 8500064848
08662402144
drrkswami@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,MSACRI,JAIPUR  Approved 
INSTITUTIONAL ETHICAL COMMITTEE,NADRI,BENGALURU  Approved 
Institutional Ethical committee,NARIVBD,Vijayawada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Bronchial Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kanakasava, Trivrit churna  1.Kanakasava 20ml twice daily with luke warm water for 12 weeks. 2.Trivrit churna 3gm during bed time with luke warm water for 12 weeks. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex with age between 18 to 60 years.
2.Patients with stable Bronchial Asthma (Tamaka Swasa) (as per GINA Guideline) for at least 6 weeks prior to study entry.
3.Subjects with intermittent & mild persistent controlled bronchial asthma & show >12 % improvement in FEV1 after bronchodilator.
4.FEV1 of > 80% of predicted value.
5.Patients willing to participate and written consent.
 
 
ExclusionCriteria 
Details  1.Patients with FEV1 < 80% of the predicted value.
2.Patients with evidence of malignancy.
3.Patients with uncontrolled Diabetes Mellitus of HbA1c>7.5%.
4.Patients with unstable cardio vascular disease.
5.Patients with uncontrolled hypertension
6.Patients who needs rescue medication daily e.g. Salbutamol inhaler.
7.Patients suffering from other major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
8.Patients with concurrent serious hepatic disorder or Renal Disorders
9.Pulmonary disease other than bronchial asthma.
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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome Measure
•Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week.
•PEFR assessments of personal best peak flow every 15 days to the end of the trial 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome Measures
•Change in St George‟s Respiratory Questionnaire (SGRQ-C) from the baseline, at the end of 4th week, 8th week & 12th week 		 12 weeks 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   06/12/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published after completion of the study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is aiming in generating the evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations. A multi centric clinical trial has been initiated in Bronchial asthma at 3 peripheral Institutes of Central Council for Research in Ayurvedic Sciences as an activity under Annul Action plan. Ayurvedic medicines Kanakasava 20ml twice daily after food, Trivrit churna 3gm during bedtime will be given for 12 weeks in 210 patients of Bronchial Asthma. This study will be conducted in 3 centres in India and completed in 2 years duration. The primary out come measures will be Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week. PEFR assessments of Personal best peak flow every 15days to the end of the trial. Secondary outcome measures will be change in St. George’s Respiratory Questionnaire(SGRQ-C) from the baseline, at the end of 4th week,8th week & 12th week.  
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