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CTRI Number  CTRI/2024/12/077927 [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   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The effect of Marma Chikitsa in varicose veins will be evaluated in 30 participants. 
Scientific Title of Study   To evaluate the effect of marma chikitsa in the management of varicose veins 
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 Deependra Singh Rathore 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  8109195869  
Fax    
Email  ds3403010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swatantra Kumar Chourasia 
Designation  Lecturer Department Of Rachna Sharir 
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  8109359509  
Fax    
Email  drswatantrachourasia.2014@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deependra Singh Rathore 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  8109195869  
Fax    
Email  ds3403010@gmail.com  
 
Source of Monetary or Material Support  
PG Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh 
 
Primary Sponsor  
Name  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh 
Address  PG Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh 
Type of Sponsor  Government funding agency 
 
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 Deependra Singh Rathore  Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh  Post Graduate Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 		 8109195869

ds3403010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Pandit Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal Madhya Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: SIRAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Dr Sunil Kumar Joshi, Procedure details: Marma sthana to be stimulated for 0.8 sec for 15-18 times once a day.)
2Comparator ArmDrugOther than Classical(1) Medicine Name: Roasted wheat flour , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukhoshn Jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 The patient having signs and symptoms of varicose veins.
2 Diagnosed case of varicose vein in lower limb.
3 Age – 20 to 65 years
4 CEAP score – C1 to C3
5 Patient who agreed to sign written consent to participate in the study. 
 
ExclusionCriteria 
Details  1 Patient having history of diabetes mellitus, hypertension, tuberculosis, malignancy, HIV.
2 Patient suffering from congenital varicose veins.
3 Patient suffering from secondary varicose veins like DVT, venous ulceration and recurrent
thrombophlebitis.
4 Patient suffering from any flared disease like psoriasis and dermatitis.
5 Pregnancy or lactating mother.
6 Patient has a history of recent surgery or trauma.
7 CEAP score - greater than C3. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study, the scholar will be able to evaluate the effect of Marma
Chikitsa in the management of varicose veins.  		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Marma Chikitsa is cost effective therapy for the management of varicose veins.  15 days 
 
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   N/A 
Date of First Enrollment (India)   20/12/2024 
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   Varicose veins are twisted, swollen blood vessels. Incidence of varicose veins increased consistently with age from 9.8% in those aged 18-34 years to 25.7% in those aged 55-64 years. Marma chikitsa is neuro modulation therapy and an innovation of ayurveda which can be applied as additional therapy for the treatment of varicose veins. 
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