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CTRI Number  CTRI/2020/06/025913 [Registered on: 16/06/2020] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [An Open Labeled, Randomized, Comparative,Controlled, Clinical Trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Ayurveda in Shwasa Roga in children 
Scientific Title of Study   A Comparative Clinical Study of Kantakari Avaleha and Chitrakaharitaki Avaleha on Tamaka Shwasa (Bronchial Asthma) in Children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagar M Bhinde 
Designation  Assistant professor 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Kuamarbhritya OPD IPGT RA Hospital Jamnagar
Kaumarbhritya department IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9662512158  
Fax    
Email  sgrbhinde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V K Kori 
Designation  Assistant Professor 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Office no 532 Kaumarbhritya Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9374548475  
Fax    
Email  drvkkori@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof K S Patel 
Designation  Professor and HOD 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Office no 531 Kaumarbhritya Department 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 of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda,Gujarat Ayurved University, Jamnagar, Gujarat 
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 
Dr Sagar Bhinde  IPGTRA  Kaumarbhritya OPD number 15 Department of Kaumarbhritya IPGT RA Gujarat Ayurved University
Jamnagar
GUJARAT 		 9662512158

sgrbhinde@ayurveduniversity.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committe Institute for Post Graduate Teaching and Research in Ayurveda,Gujarat Ayurved University, Jamnagar  Approved 
Institutional Ethics Committe Institute for Post Graduate Teaching and Research in Ayurveda,Gujarat Ayurved University, Jamnagar  Approved 
Institutional Ethics Committe 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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Kantakari Avaleha  Kantakari Avaleha will be given in the age group 2-16 years of either sex for 08 weeks Dose will be calculated by using Sharangdhara formula that is adult dose multiply with age of child in year divided with sixteen Here adult dose is 40 g per day Rout of drug administration is oral Frequency will be 3 times a day after breakfast lunch and dinner with luke warm water  
Comparator Agent  Group B Chitraka Haritaki Avaleha   Chitraka Haritaki Avaleha will be given in the age group 2-16 of either sex for 08 weeks Dose of drug will be calculated by using Sharangdhara formula that is adult dose multiply with age of child in year divided with sixteen Here adult dose is 40 g per day Rout of drug administration is oral Frequency will be 3 times a day after breakfast lunch and dinner with luke warm water 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patients of 2 – 16 years of age in either sex
2. Patients having any 4 or more classical symptoms of Tamaka Shwasa.
3. Diagnosed cases of bronchial asthma with at least 3 episodes of symptoms within a year.
 
 
ExclusionCriteria 
Details  1 Patients of < 2 year and > 16 years of age
2 Patient came during status asthmaticus
3 Evidence of active pulmonary disease other than asthma
4 Evidence of requirement of intubations for asthma within one month before
5. Patients having unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 3 weeks.
6. Concomitant severe de-compensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Partial or complete remission of bronchial Asthma  Baseline 8 weeks and 12 week 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in breathlessness  Baseline 8 weeks and 12 week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2020 
Date of Study Completion (India) 28/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. Bhinde SM, Bhinde SS, Kori VK, Patel KS. A compendious review of Chitraka Haritaki Avaleha – A polyherbal Ayurveda formulation for bronchial asthma.” AYU 2021;41:12-8. DOI: 10.4103/ayu.AYU_340_20 2. Bhinde SM, Bhinde SS, Kori VK, Patel KS. A bird’s eye view on Kantakari Avaleha: A polyherbal Ayurveda formulation for bronchial asthma. BLDE Univ J Health Sci 2022;7:171-8 3. Bhinde SM, Bhinde SS, Shukla VJ, Cholera M, Harisha CR, Kori VK. Pharmaceutical evaluation of modified Kantakari Avaleha for pediatric use. J Drug Res Ayurvedic Sci 2023;8:262-70.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The study design of present clinical trial was open labelled, randomized controlled clinical trial. The clinical study was started after getting approval of IEC (vide ref. - PGT/7/-A/Ethics/2019-2020/3158 dated 30/03/2020). The trial is also registered in CTRI prospectively (CTRI/2020/06/025913 registered on: 1/06/2020). First enrolment was on 26/08/2020 and last patient enrolled on 21/10/2022. During this period, total 104 patients of Tamaka Shwasa have been screened, out of which 100 patients were registered in the study. Among them 80 were completed the trial along with follow-up and 20 patients didn’t complete the trial due to various reasons. In the present clinical trial, subjects were randomly allocated into two groups according to Sequentially numbered opaque sealed envelope (SNOSE). Group A: Kantakari Avaleha and group B: Chitraka Haritaki Avaleha. Drugs were given in below mentioned dose in three divided doses after meal with lukewarm water for a period of 8 weeks with 4 weeks of follow up. After 8 weeks, use of Kantakari Avaleha (Group A) showed statistical significant improvement in all the cardinal symptoms, Agni Bala, PEFR, RR, BHT, Level of Asthma control, ACT and in ACQ; while insignificant changes were seen in all haematological parameters except Total RBC count (which also remains in normal limit only). 
Chitrakaharitaki Avaleha (Group B) showed significant improvement in all the cardinal symptoms, Agni Bala, PEFR, RR, Level of Asthma control, ACT score and in total ACQ; while insignificant changes were seen in all haematological parameters except Basophil count.
On comparison of the groups, significant difference was found in Shwasakashtta, Pinasa, Krichchhratbhashitam, ACT and ACQ. (group B is better than group A)
 
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