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CTRI Number  CTRI/2024/12/077780 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect Of Modified Method Of Agnikarma In Knee Joint Arthritis e 
Scientific Title of Study   A Clinical Study On Modified Method Of Agnikarma In The Management Of Janu Sandhigata Vata (Osteoarthritis Of Knee Joint) 
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 Miti M Virani 
Designation  Ph.D Scholar 
Affiliation  J. S. Ayurveda Mahavidyalaya Nadiad 
Address  J S Ayurved Mahavidyalaya & P D Patel Ayurveda Hospital, Department of Panchakarma, College road, Near Vaniyavad, Nadiad 387001

Kheda
GUJARAT
387001
India 
Phone  9624921548  
Fax    
Email  drmiti1602@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr. Kalapi B Patel 
Designation  Principal & Superintendent 
Affiliation  J S Ayurveda Mahavidyalaya 
Address  Principal office J S Ayurved Mahavidyalaya & P D Patel Ayurveda Hospital, College road, Nadiad 387001

Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Miti Virani  
Designation  PhD scholar  
Affiliation  J S Ayurveda Mahavidyalaya 
Address  J S Ayurveda Mahavidyalaya & P D Patel Ayurveda Hospital, Department of Panchakarma, College road, Near vaniyavad, Nadiad 387001

Kheda
GUJARAT
387001
India 
Phone  9624921548  
Fax    
Email  drmiti1602@gmail.com  
 
Source of Monetary or Material Support  
J S Ayurveda Mahavidyalaya & P D Patel Ayurveda Hospital, Department of Panchakarma, College road, Nadiad 387001 
 
Primary Sponsor  
Name  J S Ayurved Mahavidyalaya 
Address  J S Ayurved Mahavidyalaya, College road, Nadiad 387001 
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 Miti Virani  J S Ayurveda mahavidyalaya & P D Patel Ayurveda hospital  Department of Panchakarma J S Ayurveda Mahavidyalaya Vaniyavad Nadiad 387001
Kheda
GUJARAT 		 9624921548

drmiti1602@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
J S Ayurveda Mahavidyalaya Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita sutra sthana 12/10, Procedure details: Agnikarma is therapeutic procedure mentioned in classical Ayurvedic texts for the management of pain. It includes application of hot Shalaka or rod directly on the skin over the painful point of the body part. Agnikarma with this classical method causes local burning of the skin, blister, wound & scar. The modified method of Agnikarma used for present clinical study includes covering of the skin over the painful point of the body part with fresh leave of Arka i.e calotropis procera & heat is being given by applying burning spirit swab having little flam & held properly with artery forceps on the leaf. Burning of the skin, blister, wound & scar formation which is always there in classical method can be prevented in this method. Care is to be taken that the cutaneous sensations of patient are normal. This procedure will be repeated daily for 15 days. Follow up will be taken after 15 days. )
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients fulfilling the diagnostic criteria of Janu Sandhigata Vata 
 
ExclusionCriteria 
Details  1. Patient suffering from any other co morbid clinical conditions along with osteoarthritis like osteoporosis, metastasis in the bones, diabetes mellitus etc.
2. Patients having previous history of arthroscopy and/or knee joint surgeries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in signs, symptoms and VAS for pain & WOMAC Scale. Assessment will be done with the help of changes in gradation of the sign and symptoms of Janu Sandhigata Vata.
 		 After 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the loco-motor activities of the patients.  15 Days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) 30/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 This is a single arm, non randomized, clinical study consists minimum 100 patients of Knee joint osteoarthritis.  The aim of this study is To find out the effectiveness of modified method of Agnikarma in management of Janu Sandhigata Vata and the objective is To find out the changes in the sign and symptoms of the Janu Sandhigata Vata after Agnikarma procedure. 
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