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CTRI Number  CTRI/2025/05/086545 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison Of Marma Therapy And Tens In Managing Kukundara Marma Injury 
Scientific Title of Study   Comparative Therapeutic Evaluation Of Marma Chikitsa And Tens Therapy In Marmaghata WSR To Kukundara Marma 
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 Prakash Sutar 
Designation  Pg Scholar 
Affiliation  MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN 
Address  Pg Department Of Rachana Sharir Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001

Udaipur
RAJASTHAN
313001
India 
Phone  7387375471  
Fax    
Email  prakashsuthar500@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Jitendra Kumar Sharma 
Designation  Professor 
Affiliation  MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN 
Address  Pg Department Of Rachana Sharir Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9784988488  
Fax    
Email  jk2011sharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Sutar 
Designation  Pg Scholar 
Affiliation  MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN 
Address  Pg Department Of Rachana Sharir Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001

Udaipur
RAJASTHAN
313001
India 
Phone  7387375471  
Fax    
Email  prakashsuthar500@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt Ayurved College, Ambamata,Udaipur 313001, Rajasthan, India 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College udaipur  
Address  Pg Department Of Rachana Sharir Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Type of Sponsor  Government medical 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 Prakash sutar  Madan Mohan Malviya Govt ayurved college udaipur  Pg department of rachana sharir Udaipur
Udaipur
RAJASTHAN 		 7387375471

prakashsuthar500@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MMM Govt Ayurved College Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M259||Joint disorder, unspecified. Ayurveda Condition: MARMAVIDDHAH/MARMABIGHATAH/MARMAKSHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-TENS THERAPYTens therapy- 100hz frequency with continuos stream mode for 10 mins per point . Group B- TENS Therapy
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा , TENS Therapy (Procedure Reference: Angirasi Chikitsa, Procedure details: Combined Therapy of Marma chikitsa-Press & release marm points 15 times per point one time a day Tens therapy- 100hz frequency with continuos stream mode for 10 mins per point . Divided in 3 groups, A- marma chikitsa , B- TENS therapy, C- Combined therapy)
3Comparator ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Angirasi chikitsa, Procedure details: Marma chikitsa-Press & release marm points 15 times per point one time a day Group A- marma chikitsa)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with classical signs and symptoms of Kukundara Marmaghata. Subjects ready to give written informed consent.Patients who are mentally and physically fit for therapy. 
 
ExclusionCriteria 
Details  Who are not ready to give written informed consent.Patients with congenital anomalies related to spine, lower back.Patient with uncontrolled DM, HTN.Patients with age below 18yrs. and above 60yrs.Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction and improvement in symptoms of kukundara marmaghata and also improvement in low back mobility.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that at the end of study we will be able to evaluate effect of Marma Chikitsa and TENS
therapy ni Kukundara Marmaghata Lakshana. 		 30 DAYS 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   01/07/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prakashsuthar500@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study focuses on the anatomical and therapeutic aspects of Kukundara marma and its Marmaghata .The research integrates Ayurvedic and modern perspectives to provide understanding of kukundara marma and its Marmaghata.
 
Key Objectives: 

Anatomical Study - Analyzing the Location and Structure of Kukundara Marma based on descriptions in Ayurvedic texts and contemporary medical science. 

Cadaveric Dissection - Examining the structural components of Kukundara marma through dissection to validate anatomical references. 

Understanding Kukundara Marmaghata - Reviewing Ayurvedic references of Marmaghata symptoms and modern literature to define the pathology of Kukundara Marmaghata.

Therapeutic Evaluation of Marma Chikitsa - Assessing the effectiveness of traditional Ayurvedic Marma therapy in managing kukundara marmaghata symptoms. 

Therapeutic Evaluation of TENS Therapy-Investigating the role of TENS therapy in relieving pain and other symptoms . 

A sample size of 90 subjects will be included in the clinical trial, ensuring diversity in gender and other demographic factors. The study aims to compare the effectiveness of Marma Chikitsa and TENS therapy in managing Kukundara Marmaghata symptoms, contributing to integrated treatment approaches.
 
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