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CTRI Number  CTRI/2021/11/037951 [Registered on: 11/11/2021] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [AGNI KARMA]  
Study Design  Single Arm Study 
Public Title of Study   A study of Thermal cautery (Agnikarma) in treatment of Achilles Tendinitis. 
Scientific Title of Study   A Single arm clinical study to evaluate the efficacy of Agnikarma with Rajata Shalaka in the management of Vatakantaka (Achilles Tendinitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PRATHAMESH PRADEEP KASHIKAR  
Designation  M S SCHOLAR SHALYATANTRA  
Affiliation  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 
Address  OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR

Pune
MAHARASHTRA
411018
India 
Phone  7767898627  
Fax    
Email  prathameshkashikar01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SANJAY CHANDRAKANT BABAR 
Designation  PROFESSOR AND HEAD OF DEPARTMENT SHALYATANTRA DEPARTMENT 
Affiliation  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 
Address  OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SANJAY CHANDRAKANT BABAR 
Designation  PROFESSOR AND HEAD OF DEPARTMENT SHALYATANTRA DEPARTMENT 
Affiliation  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 
Address  OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR
OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmail.com  
 
Source of Monetary or Material Support  
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 DEEMED TO BE UNIVERSITY 
 
Primary Sponsor  
Name  DR PRATHAMESH PRADEEP KASHIKAR 
Address  OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 
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 PRATHAMESH PRADEEP KASHIKAR  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18  OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18
Pune
MAHARASHTRA 		 7767898627

prathameshkashikar01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH AND RECOGNITION COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: VATAKANTAKAM ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma (viShopakramaH), अग्निकर्म (विषोपक्रमः) (Procedure Reference: Sushrut sutrastan 12/20, Procedure details: Agnikarma will be done with Rajata Shalaka at the site of Achilles Tendon on 0th and 7th day by Bindu (dot) type of Agnikarma method. The Agnikarma will be done as per classical method and all the SOP will be followed. Follow up will be on 7th and 14th day. Total study duration will be of 14 days.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms at site of Achilles Tendon such as: Pain, Tenderness, Unable to bear body weight on affected leg, Difficulty in walking. 
 
ExclusionCriteria 
Details  1) Calcaneal spur
2) Plantar Fasciitis
3) Dislocation & fracture of ankle joint
4) Ulcers such as varicose ulcer, trophic ulcers
5) Patients having uncontrolled Diabetes Mellitus.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the action of Agnikarma with Rajata Shalaka for relieving pain in Achilles Tendinitis.  Agnikarma will be done on 0th and 7th day.
Follow-ups will be on 7th and 14th day.
Total duration of study will be 14 days. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To provide safe and cost effective treatment for relieving pain in Achilles Tendinitis.
2) To observe the adverse effects of agnikarma. 		 Agnikarma will be done on 0th and 7th day.
Follow-ups will be on 7th and 14th day.
Total duration of study will be 14 days. 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   01/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/01/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a single arm clinical study in which Agnikarma with Rajata Shalaka will be carried out on 31 pre-diagnosed patients of Vatakantaka (Achilles Tendinitis) for relieving pain.
the Agnikarma will be done on 0th and 7th day. Follow-up will be on 7th and 14th day and total duration of the study will be 14 days. The age group taken for the study trial will be between 18 years and upto 60 years.
 
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