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CTRI Number  CTRI/2025/08/093911 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 17/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between two ayurvedic medicines for Allergic bronchitis 
Scientific Title of Study   Comparitive study of Kasahar mahakashay and Panchmooli kwath in Vataj kasa w.s.r to Allergic bronchitis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPratima Dilip Ghate 
Designation  PhD scholar 
Affiliation  Ananya Ayurved College and hosital Kolol 
Address  Ananya Ayurvedic College Hospital KIRC campus Kolol Mehsana highway Kolol Gandhinagar

Gandhinagar
GUJARAT
382721
India 
Phone  9822263555  
Fax    
Email  dr.pratimaghate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPradip Kumar Panda 
Designation  Professor,Dean 
Affiliation  Sri Sri Ayurvedic College Cuttack 
Address  Sri Sri Ayurvedic college and hospital Sri Sri Univesity Cuttack Orissa

Cuttack
ORISSA
754006
India 
Phone  9437150643  
Fax    
Email  deansscasrh@srisriuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Durgaprasad Dash 
Designation  Professor 
Affiliation  Sri Sri Ayurvedic College Cuttack 
Address  Sri Sri Ayurvedic college and hospital Sri Sri Univesity Cuttack Orissa

Cuttack
ORISSA
754006
India 
Phone  9853435916  
Fax    
Email  durga.d@srisriuniversity.edu.in  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  DrPratima Dilip Ghate 
Address  KIRC campus Kolol Kolol Mehsana Highway Kolol Gandhinagar 
Type of Sponsor  Other [Self] 
 
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 
DrPratima Dilip Ghate  Ananya Ayurved Hospital  Kayachikitsa OPD KIRC Campus Kolol Mehsana highway Kolol Gandhinagar Gujarat 382721
Gandhinagar
GUJARAT 		 09822263555

dr.pratimaghate@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC for Biomedical Research of Faculty of Health and wellness Sri Sri college of Ayurvedic Science and Research hospital Cuttack Orissa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchmooli Kwath, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kasahar Mahakashay, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient from 17-60 years of age having signs and symptoms of vataj kasa and allergic bronchitis 
 
ExclusionCriteria 
Details  Patient below 17 year and above 60 years of ageChronic lung diseases COPD TB Carcinoma pregnancy lactation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
There may be significant effect of Kasahar Mahakashay and Panchmooli kwath in the management of Kasa  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
This clinical study will be effective in allergic conditions & also enhances immuno modulating actions  30 days 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   05/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.pratimaghate@gmail.com].

  6. For how long will this data be available start date provided 02-11-1970 and end date provided 02-01-1970?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		  This is a comparitive randomized clinical study  to assess their efficacy in Vataj kasa with special reference to allergic bronchitis.Due to rapid industialization ,urbanization,increased pollutants with the high  level of susceptibility of infections make the natural resistance of the human body weaker,leading to different clinical conditions. One such respiratory illness is vataj kasa vyadhi .Cough is the second most common symptom  to the extent of 4.29% prevalence in the primary care practice in india. If it becomes more chronic ,can cause impairement of the quality of life.The description of vataj kasa vyadhi mentioned in ayurvedic classics can be corelated with Allergic bronchitis.The concept of asatmya that is unfavourable mentioned in charak samhita can be compared with this condition.Hence a need to find an effective medication for the treatment of vataj kasa vyadhi. In proposed research plan two kashayas that is Kasahar mahakashay and panchmooli kwath were selected from ayurvedic classics with the aim to evaluate and compare their efficacy and also to assess the efficacy in Absolute eosinophil count and immunoglobulin E.

 
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