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CTRI Number  CTRI/2025/02/079977 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical study to compare the effect of two ghee preparations in healing burn injury as apart of treatment of corn  
Scientific Title of Study   A Pragmatic comparative clinical trial to evaluate effectiveness of topical application of Jiraka Ghrta against Yashtimadhuadi Ghrta in Agnidagdha Vrana after Corn excision 
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 Ajith Narayanan A M 
Designation  PG Scholar 
Affiliation  VPSV Ayurveda college Kottakkal 
Address  Department of Shalyatantra VPSV Ayurveda college Kottakkal. Malappuram district Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  7559920688  
Fax    
Email  ajithappu85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunitha P V 
Designation  Professor 
Affiliation  VPSV Ayurveda college Kottakkal 
Address  Department of Shalyatantra VPSV Ayurveda college Kottakkal. Malappuram district Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9447991388  
Fax    
Email  drsunitapv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunitha P V 
Designation  Professor 
Affiliation  VPSV Ayurveda college Kottakkal 
Address  Department of Shalyatantra VPSV Ayurveda college Kottakkal. Malappuram district Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9447991388  
Fax    
Email  drsunitapv@gmail.com  
 
Source of Monetary or Material Support  
Arya Vaidya Sala Kottakkal GMP CERTIFIED INSTITUTE ,Malapppuram Kerala, India Pin :676503  
 
Primary Sponsor  
Name  VPSV Ayurveda College Kottakkal 
Address  VPSV Ayurveda college Kottakkal Edarikkode PO Kottakkal Kerala 676501  
Type of Sponsor  Other [[Aided College]] 
 
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 Ajith Narayanan A M  VPSV Ayurveda college hospital   OPD Shalyatantra VPSV Ayurveda college Hospital Kottakkal Room no 101A
Malappuram
KERALA 		 7559920688

ajithappu85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: KADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Yashtimadhuadi ghrtham, Reference: Susrutha samhitha Agnikarma vidhi adyaya chapter 12 sloka number 27 & 28, Route: Topical, Dosage Form: Ghrita, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -topical application
2Intervention ArmDrugClassical(1) Medicine Name: Jiraka Ghrtha, Reference: Bhaishajya ratnavali chapter 48 th chapter Sadhyavrana chikitsa sloka no 17, Route: Topical, Dosage Form: Ghrita, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects with informed consent.
2.Subjects satisfying diagnostic criteria.
 
 
ExclusionCriteria 
Details  1.Subjects having difficulty in reaching OPD on alternative days will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Size of the wound- Diameter and depth
2. Discharge from wound
3. Pain by using Visual Analogue Scale 		 0th 6th and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/02/2025 
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   A pragmatic  trial is planned in Corn (Kadara) after excision and agnikarma to heal the wound by comparing Yashtimadhuadi ghrta and Jeeraka ghrta. Burns are very common and has the global prevalence of 6-7 million per year. There are so many medicines in Ayurveda which are beneficial in treating burns. One such yoga mentioned in Susruta samhita sutrasthana Agnikarma vidhi is Yashtimadhuadi ghrta. It contains 8 drugs having the property of RopanÌ£a. There are simple formulations available in the latterly evolved classical Ayurvedic books, which are found to be effective in clinical practice but not yet scientifically validated.  JiÌ„raka GhrÌ£ta is a formulation explained in the context of AgnidagdhavranÌ£a CikitsaÌ„dhikaÌ„ra consisting of easily available drugs like JiÌ„raka, Sarjarasa and MadhuÌ„cchisÌ£tÌ£a which can be easily prepared. This study  will be done in 15 participants in each group for a period of 14 days, in the age group of 21-70 years. Participants diagnosed as per diagnostic criteria and satisfying inclusion criteria will be selected consecutively into 2 groups from the OPD of VPSV Ayurveda College Hospital, Kottakkal. After Agnikarma, Group 1 participants will be dressed with JiÌ„raka GhrÌ£ta, and Group 2 participants will be dressed with YasÌ£tÌ£iÌ„madhuaÌ„di GhrÌ£ta once in alternative days up to 14 days. Assessment will be done on subjective parameters like pain and burning sensation and objective parameters like size of wound and discharge. Data will be analysed using appropriate Statistical tests. 
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