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CTRI Number  CTRI/2022/09/045850 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 13/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Marma Chikitsa for neck pain 
Scientific Title of Study   Comparative study of marma chikitsa and physiotherapy in greevashola (neck pain): an open label randomized controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Singh 
Designation  Assistant Professor 
Affiliation  Main campus Uttarakhand Ayurved University Harrawalla Dehradun Uttarakhand 
Address  OPD No. 6 , Shalya Tantra Department, Main campus, Uttarakhand Ayurved University, Harrawalla Dehradun Uttarakhand

Dehradun
UTTARANCHAL
249201
India 
Phone  07409570303  
Fax    
Email  archana8580singh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Sunil Kumar Joshi 
Designation  Professor 
Affiliation  Main campus Uttarakhand Ayurved University Harrawalla Dehradun Uttarakhand 
Address  OPD No. 6 , Shalya Tantra Department, Main campus, Uttarakhand Ayurved University, Harrawalla Dehradun Uttarakhand

Dehradun
UTTARANCHAL
249201
India 
Phone  9897523499  
Fax    
Email  mrityunjaymission@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Singh 
Designation  Assistant Professor 
Affiliation  Main campus Uttarakhand Ayurved University Harrawalla Dehradun Uttarakhand 
Address  OPD No. 6 , Shalya Tantra Department, Main campus, Uttarakhand Ayurved University, Harrawalla Dehradun Uttarakhand

Dehradun
UTTARANCHAL
249201
India 
Phone  07409570303  
Fax    
Email  archana8580singh@gmail.com  
 
Source of Monetary or Material Support  
Shalya Tantra OPD and IPD, Main Campus, Uttarakhand Ayurved University, Harrawal, Dehradun, Uttarakhand  
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Harrawal, Dehradun, Uttarakhand 
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 Archana Singh  Main Campus, U.A.U  Shalya Tantra OPD and IPD, Main Campus,Uttarakhand Ayurved University, Harrawal, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL 		 07409570303

archana8580singh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Uttarakhand Ayurved University, Harrawala, Dehradun, Uttarakhand  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M799||Soft tissue disorder, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: , Procedure details: Krikatika,Amsa, Amsaphalak Marma of back along with Kshipra, Kurpara Marma of hands will be stimulated for 18-28 times in one session. 3 times/sessons par day will be done for 6 weeks.)
2Comparator ArmProcedure-physiotherapy (Procedure Reference: , Procedure details: Trans Cutaneous Electrical Nerve Stimulation (TENS)will be done for 6 days.)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting classical signs and symptoms of greevashool (Neck pain).
2. Willingness of patient.
3. All the conditions explained apart from the exclusion criteria are included.

 
 
ExclusionCriteria 
Details  1. Infectious diseases of the Cervical spine
2. Congenital/Developmental disorders of neck pain such as Kyphoscoliosis, Spina bifida occulta and tethered spinal cord
3. Metabolic spine disorders such as Osteosclerosis (Paget’s disease)
4. Fracture or dislocation in cervical region
5. Patients with neoplastic growth
6. Patients with history of cervical spine trauma
7. Spondylolisthesis
8. Other forms of Arthritis- rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and juvenile idiopathic arthritis.
9. Pregnant women.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
outcome will be assessed based on following parameters-
Subjective criterion
1. Greeva shoola
2. Greeva stambha
3. Daurbalya
4. Shoolaagamna
5. Bhrama
Chimchimayana hasta
Objective criterion
!. Tenderness over cervical region
2. Movement of the neck
3. Neck disability index
 		 duration of treatment is 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
relief in neck pain  6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   28/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/09/2022 
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 Yet Recruiting 
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   Title of Study: Comparative study of Marm chikitsa and Physiotherapy in Greevashoola (neck Pain): an open label randomized controlled trial.
In this study, a total of 100 neck pain patients will be selected from OPD/IPD of main campus, Uttarakhand Ayurved University, Harrawala, Dehradun and the study will be conducted on randomly divided two groups (50 patients in each group).
Assessment will be carried out on weekly interval for six weeks i.e. 1st, 7th, 14th,21st, 28th and 42nd day to find out the efficacy of Marma Chikitsa and physiotherapy.
 
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