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CTRI Number  CTRI/2025/08/092754 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
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   A study to test the effectiveness of Pippalyadi yoga in treating cough in children. 
Scientific Title of Study   Randomised controlled clinical trial to evaluate the efficacy of Pippalyadi yoga in Kaphaja kasa in children. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rudresh Bhujaji Gawali 
Designation  PG scholar 
Affiliation  late ledari redekar ayurvedic mahavidyala,Gadhinglaj,Kolhapur 
Address  Late Kedari Redekar Ayurvedic Mahavidyala and post graduate research centre, Ground floor Balaroga department, shendri mal road Gadhinglaj Kolhapur Maharashtra 416502 India.

Kolhapur
MAHARASHTRA
416502
India 
Phone  7888273233  
Fax    
Email  gawalirudresh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Asmita Yesane 
Designation  professor of balaroga department 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya 
Address  Late Kedari Redekar Ayurvedic Mahavidyala and post graduate research centre, Ground floor Balaroga department, Shendri mal road, Gadhinglaj Kolhapur Maharashtra 416502 India.

Kolhapur
MAHARASHTRA
416502
India 
Phone  9552635237  
Fax    
Email  shindeasmita@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAsmita Yesane 
Designation  professor of balaroga department 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya 
Address  Late Kedari Redekar Ayurvedic Mahavidyala and post graduate research centre, Ground floor Balaroga department, Shendri mal road, Gadhinglaj Kolhapur Maharashtra 416502 India.

Kolhapur
MAHARASHTRA
416502
India 
Phone  9552635237  
Fax    
Email  shindeasmita@gmail.com  
 
Source of Monetary or Material Support  
Late Kedari Redekar Ayurvedic Mahavidyala and post graduate research centre,Shendri mal road, Gadhinglaj Kolhapur Maharashtra 416502 India. 
 
Primary Sponsor  
Name  Dr Rudresh Bhujaji Gawali 
Address  Late Kedari Redekar Ayurvedic Mahavidyala and post graduate research centre, room no 2, Ground floor Balaroga department, Shendri mal road, Gadhinglaj Kolhapur Maharashtra 416502 India. 
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 
Dr Rudresh Bhujaji Gawali  Late kedari Redekar ayurvedic mahavidyalaya,Gadhinglaj,Kolhapur  Room no 2, Ground floor Balaroga department, Shendri mal road, Gadhinglaj Kolhapur Maharashtra 416502 India.
Kolhapur
MAHARASHTRA 		 07888273233

gawalirudresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  cough 
Patients  (1) ICD-10 Condition:J029||Acute pharyngitis, unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kaphaja kasahara pippali, Reference: cha.chi.18/116, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7.2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -kulattha kwath), Additional Information: -
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Productive cough associated with or without other symptoms described in the context of Kaphaja Kasa will be included.
2.Kaphajkasa less than 15 days duration will be selected.
3.Patients will be selected irrespective of sex, Caste between the age group of 8 - 12 yrs. 
 
ExclusionCriteria 
Details  1.All types of kasa except kaphajkasa.
2.Kasa as an anubandhalakshana in already diagnosed patients like Pneumonia, Emphysema, Asthma.
3.Age less than 8yrs and more than 12yrs 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome focuses on the clinical efficacy of pippalyadi yoga in managing kaphaja kasa in children. It will be assessed based on symptomatic relief (frequency of bouts of cough, Nasal discharge, aruchi and Sputum) and objective parameter.  10 days treatment with 3 follow ups on 4th, 7th and 10 th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Pippalyadi churna is more effective than sitopaladi churna  Initial Assessment at 0 day
Follow up 4th,7th & 10th day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   20/08/2025 
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="1"
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 - NO
Brief Summary   Cough is the 5th common for which patients seek care and prevalence rate of which is 25% in children worldwide. The traditional Indian medicine gives specific line of treatment and various remedies on kaphaja Kasa (productive cough) as prescribed in text. That’s why this subject for study has been chosen. 
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