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CTRI Number  CTRI/2023/01/048931 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 11/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   TO EVALUATE THE EFFECT OF MARMA CHIKITSA (VITAL POINT) IN THE MANAGEMENT OF GRIDHRASI (SCIATICA) 
Scientific Title of Study   To Evaluate The Effect Of Marma Chikitsa In The Management Of Gridhrasi (Sciatica) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Gupta 
Designation  MD Scholar  
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India 
Phone  9540441041  
Fax    
Email  rahulguptaji0091@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Gupta 
Designation  MD Ayu. Assistant Professor 
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India 
Phone  9425647011  
Fax    
Email  drpankaj35@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Gupta 
Designation  MD Scholar  
Affiliation  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India 
Phone  9540441041  
Fax    
Email  rahulguptaji0091@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
 
Primary Sponsor  
Name  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
Address  Post Graduate Department of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
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 Rahul Gupta  Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP  Post Graduate Department of Rachna Sharir/room no 41 Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP/
Bhopal
MADHYA PRADESH 		 9540441041

rahulguptaji0091@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Placebo Control15 patients of this group will be given placebo control (Rosted Wheat Flour capsule). Dose - 2 capsule (each 250mg) BD, After meal Anupana – Sukoshna jala Study Duration – 2 Month Follow-up Duration – 1 Month
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: MARMA SCIENCE AND PRINCIPLES OF MARMA THERAPY Dr. S. K. Joshi, , Procedure details: According to their anatomical location of Marma points, Gulpha and Kshipra Marma point will be stimulated by pulp of thumb for 15-18 times on an average in single sitting.EACH STIMULUS WILL BE GIVEN FOR 0.8 SECONDS A steady and moderate pressure will be applied by pulp of thumb slowly and gently. Pressure will be increased gradually depending upon patient strength.) Study Duration – 2 Month Follow-up Duration – 1 Month))
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex in the age group of 20 to 60 years.
Clinical presentation of Gridhrasi
Positive SLR test
Tenderness of the Sciatic Nerve course.
Severe pain on squatting.
Patient willing to be registered for study.  
 
ExclusionCriteria 
Details  Age group below 20 yrs. and above 60 yrs.
Any traumatic conditions of spine and hip
Fracture related to spine.
Previous surgical or medical history.
Pregnant women & lactating women.
Balyavastha (Very Young), Sthavir (Very Old), Ruksha (Perched Man), Kshata
(Wounded), Kshina (Debilitated Person), Bhiru ( Timid), Parishrant (Tired).
 
 
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 study, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Gridhrasi (Sciatica).1.Pain starting from Sphik and radiating towards Kati (Lumber), Prasthoru (Posterior of thigh),
Janu (Knee joint), Jangha (Calf), Pada(Foot) in descending order.
2.Walking time 3.SLR test 		 at the end of 1 month treatment , scholar will be able to evaluate the effect of Marma Chikitsa in the management of Gridhrasi (Sciatica).
 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that at the end of study, scholar will be able to evaluate the effect of Marma Chikitsa in the management of Gridhrasi (Sciatica).
 		 It is expected that at the end of 1 months , scholar will be able to evaluate the effect of Marma Chikitsa in the management of Gridhrasi (Sciatica).
 
 
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)   12/01/2023 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this study detail of Gridhrasi (Sciatica) will be done from literature. We will evaluate the effect of Marma Chikitsa in the management of Gridhrasi (Sciatica). 
1. Pain starting from Sphik and radiating towards Kati (Lumber), Prasthoru (Posterior of thigh), Janu (Knee joint), Jangha (Calf), Pada(Foot) in descending order.

2. Walking time

3. SLR test

 
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