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CTRI Number  CTRI/2013/03/003475 [Registered on: 12/03/2013] Trial Registered Retrospectively
Last Modified On: 11/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE STUDY OF VYAGHRI HARIKATI AVALEHA AND VASA AVALEHA IN BRONCHITIS IN CHILDREN 
Scientific Title of Study   A CLINICAL STUDY ON KASA IN CHILDREN & ITS MANAGEMENT WITH VYAGHRI HARITAKI AVALEHA AND VASA AVALEHA. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suhas Adubhai Chaudhary 
Designation  MD Scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
A 10 Sweni Flats Nava Vadaj Ahmedabad
Ahmadabad
GUJARAT
361008
India 
Phone  9427073351  
Fax    
Email  vdsuhaschaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K S Patel 
Designation  Associate Professor & Head 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr K S Patel 
Designation  Associate Professor & Head 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kaumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Jamnagar GUJARAT 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Suhas Adubhai Chaudhary  OPD Department Of Kaumarbhritya  IPGT and RA Gujarat Ayurved University Jamnagar Gujarat
Jamnagar
GUJARAT 		 9427073351

vdsuhaschaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Kasa (Bronchitis), (1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Vasa Avaleha  Vasa Avaleha - Doses - as per body wieght ( Youngs Rule ) Twice A Day Before Food With Luke Warm Water ; Duration 4 Weeks  
Intervention  Vyaghri Haritaki Avaleha  Vyaghri Haritaki Avaleha - Doses - as per body wieght ( Youngs Rule ) Twice A Day Before Food With Luke Warm Water ; Duration 4 Weeks  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  • Children of both sex belonging to age group 3 to 12 years.
• Patient presenting with the classical symptoms of Kasa as per their dosha variety (vatika, paitika, shleshmika) since 2 weeks.
 
 
ExclusionCriteria 
Details  • Age below 3 years and above 12 years.
• Patient presenting with symptoms of Tamaka shwasa (Bronchial asthma), Kshayaja & Kshataja Kasa.
• Patient presenting with Pneumonia, COPD (Emphysema). DEPTHERIA, PERTUSIS.
• Patient associated with systemic illness such as TB, HIV, and other chronic debilitating diseases.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Bouts of Cough
Duration of Cough
Frequency of Cough
 		 14 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Bouts of Cough
Duration of Cough
Frequency of Cough
Satva Bala
Agni Bala
Deha Bala  		 28 Days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   14/03/2013 
Date of Study Completion (India) 16/12/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized open ended clinical trial at IPGT and RA, Gujarat Ayurved University, Jamnagar in Department of Kaumarbhritya OPD. Both drugs Vyaghri Haritaki Avaleha and Vasa Avaleha are reference from Bhaishajya Ratnavali  which is well known book as per clinical use. Both drugs uses in Respiratory complaints like Cough, Bronchitis etc. We want to do comparative study of both drugs in disease Kasa shown in Ayurveda. In gujarat, Vasa leave juice use in bronchitis commonly as home remedy. So we take Vasa Avaleha mainly contains of Vasa leave juice. Kantakari is a well-known drug for bronchitis in Ayurveda and Vyaghri is one of the synonym of Kantakari. So we take another drug in the study is Vyaghri Haritaki Avaleha which contains Kantakari as a main contain. The study is not start yet but we think Vyaghri Haritaki Avaleha will show better result at the end of study.
 
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