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CTRI Number  CTRI/2024/12/077915 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Agnikarma In Snayugat Vata (Ankle Sprain) 
Scientific Title of Study   Experimental Study of Effect of Agnikarma With Mruttika Shalaka in Snayugat Vata With Special Reference to Ankle Sprain 
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 Nishigandha Debaje 
Designation  PG Scholar  
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli 
Address  OPD No. 1 Shalyatantra Department Hon.Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  8421124399  
Fax    
Email  debaje.nishigandha28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Jadhav 
Designation  Reader 
Affiliation  Hon Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli  
Address  OPD No. 1 Shalyatantra Department, Hon Shri Annasaheb Dange Ayurved Medical Collage Post Graduate and Research Center Ashta TAQ Walwa Dist Sangli Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  9823279290  
Fax    
Email  sjadhav21066@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Jadhav 
Designation  Reader 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli  
Address  OPD No. 1 Shalyatantra Department Hon Shri Annasaheb Dange Ayurved Medical Collage Post Graduate and Research Center Ashta TAQ Walwa Dist Sangli Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  9823279290  
Fax    
Email  sjadhav21066@gmail.com  
 
Source of Monetary or Material Support  
Hon Shri Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli 416301 
 
Primary Sponsor  
Name  Dr Nishigandha Debaje 
Address  Hon Shri Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli 416301 
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 Nishigandha Debaje  Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli  OPD No. 1 Shalyatantra Department Hon Shri Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli 416301
Sangli
MAHARASHTRA 		 8421124399

debaje.nishigandha28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli 416301  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M669||Spontaneous rupture of unspecifiedtendon. Ayurveda Condition: SNAYUGATAVATAH, (2) ICD-10 Condition:M679||Unspecified disorder of synovium and tendon. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: स्नेहोपनाहाग्निकर्मबन्धनोन्मदनानिच । स्नायुसन्ध्यस्थिप्राप्ते कुर्यात्वायावतन्द्रितः ॥ (सु.चि. ४/८), Procedure details: 1) Purva karma – 1.Informed written consent will be taken from patient 2.The selected site will be clean with normal saline . 2) Pradhana karma 1.The affected part will be cleaned with normal saline. 2.Then it will be wiping with dry sterilized cotton gauze. 3.Panchadhatu Shalaka will be heated on gas till up to red hot 4.Then 10 – 12 Samyaka Daghdha Vrana will be made by red hot Panchadhatu Shalaka with Bindhu Dahan Vishesh which will be penetrate up to Mans Dhatu over Ankle Joint region with gap of 1 -2 cm from each other. 3) Paschat karma During entire procdure Kumari swaras will be applied over the each of samkya dagdha vrana of red hot shalaka. Agnikarma will be done by Panchadhatu Shalaka at the site of maximum tenderness. After agnikarma immediately Kumari swaras (aloe vera) will be applied as a cooling agent.)
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: स्नेहोपनाहाग्निकर्मबन्धनोन्मदनानिच । स्नायुसन्ध्यस्थिप्राप्ते कुर्यात्वायावतन्द्रितः ॥ (सु.चि. ४/८), Procedure details: 1) Purva karma – 1.Informed written consent will be taken from patient 2.The selected site will be clean with normal saline . 2) Pradhana karma 1.The affected part will be cleaned with normal saline. 2.Then it will be wiping with dry sterilized cotton gauze. 3.Mruttika Shalaka will be heated on gas till up to red hot 4.Then 10 – 12 Samyaka Daghdha Vrana will be made by red hot Mruttika Shalaka with Bindhu Dahan Vishesh which will be penetrate up to Mans Dhatu over Ankle Joint region with gap of 1 -2 cm from each other. 3) Paschat karma During entire procdure Kumari swaras will be applied over the each of samkya dagdha vrana of red hot shalaka. Agnikarma will be done by Mruttika Shalaka at the site of maximum tenderness. After agnikarma immediately Kumari swaras (aloe vera) will be applied as a cooling agent. )
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age group- Patients between age group 15 to 60 yrs.
2.Sex – Irrespective of Gender.
3.Patient having typical feature of A.S
4.Patients with pain and swelling at ankle joint, radial side, spasm and Tenderness. 
 
ExclusionCriteria 
Details  1.Patients having any congenital structure
2.Patients with Pittaj Prakruti
3.Patient having facture or ligament tear
4.Patients associated with any systemic disease like diabetes mellitus HTN etc.
5.Osteoarthritis, ankle bone fracture or any malignancy.
6.previous fracture. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To Determine the efficacy of Agnikarma with Mruttika Shalaka in Snayugatavata(Ankle sprain).
2.To compare efficiency of Agnikarma with Mruttika Shalaka and Agnikarma with Panchadhatu Shalaka.
 		 Follow up on 0,7,14,21 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To observe the effect of aginkarma with Mruttika Shalaka in Snayugatvata (Ankle Sprain).
2.To observe the effect of aginkarma with Panchadhatu Shalaka in Snayugatvata (Ankle Sprain). 		 0, 7th, 14th, 21st, days  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   N/A 
Date of First Enrollment (India)   02/01/2025 
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  

TITLE :-  “EXPERIMENTAL STUDY OF EFFECT OF AGNIKARMA WITH MRUTtikA SHALAKA IN SNAYUGATA VATA WITH SPECIAL REFERENCE TO ANKLE SPRAIN”

 

Primary Research Question :- Does Agnikarma with Mruttika Shalaka effective in Snayugata Vata (Ankle Sprain)?

 

Hypothesis:-

Primary Hypothesis

H0-Agnikarma with Mruttika Shalaka is not significantly effective in treating snayugata vata (Ankle Sprain) 

H1-Agnikarma with Mruttika Shalaka is significantly effective in treating snayugata vata (Ankle Sprain)

Other Hypothesis

H0-Agnikarma with Mruttika Shalaka and Agnikarma with Panchadhatu Shalaka both are equally effective.

H1-Agnikarma with Mruttika Shalaka is more effective than Agnikarma with Panchadhatu Shalaka.

 

Primary Objectives

  1. To Determine the efficacy of Agnikarma with Mruttika Shalaka in Snayugatavata(Ankle sprain).
  2. To compare efficiency of Agnikarma with Mruttika Shalaka and Agnikarma with Panchadhatu Shalaka.

Secondary Objectives :-

  1. To observe the effect of aginkarma with Mruttika Shalaka in Snayugatvata (Ankle Sprain).
  2. To observe the effect of aginkarma with Panchadhatu Shalaka in Snayugatvata (Ankle Sprain) .

 

Inclusion Criteria

1.Age group- Patients between age group 15 to 60 yrs.

2.Sex – Irrespective of Gender.

3.Patient having typical feature of A.S

4.Patients with pain and swelling at ankle joint, radial side, spasm and Tenderness.

 

Exclusion Criteria

1.Patients having any congenital structure

2.Patients with Pittaj Prakruti

3.Patient having facture or ligament tear

4.Patients associated with any systemic disease like diabetes mellitus HTN etc.

5.Osteoarthritis, ankle bone fracture or any malignancy.

6.previous fracture.

 

Withdrawal Criteria :-

1.If patient develop any adverse effect

2.If patient refuses to continue with the treatment.

3.If patient is not responding to treatment and aggravation of symptoms.

 

Follow Up Days: - 0, 7th, 14th, 21st, days

Duration Of Treatment: - 21 days 


 
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