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CTRI Number  CTRI/2024/06/069430 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Marma Chikitsa And Agnikarma In Management of Cervical pain (Cervical Spondylosis) 
Scientific Title of Study   Comparative Clinical Study To Evaluate The Efficacy Of Marma Chikitsa And Agnikarma In Pain Management Of Cervical Spondylosis wsr to Greeva Sandhigata Vata  
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 Rahul Mehra 
Designation  MS Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajastan 
Address  P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9782133119  
Fax    
Email  rahulmehra571995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Mehra 
Designation  MS Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajastan 
Address  P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9782133119  
Fax    
Email  rahulmehra571995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishnu Dutt Sharma 
Designation  Associate Professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajastan 
Address  P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  7742042974  
Fax    
Email  ayurvishnu@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurveda Jodhpur Rajasthan India 342037 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurved Jodhpur,Rajastan 
Address  P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India 
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 Rahul Mehra  Sanjeevani hospital,post graduate institute of ayurveda  P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN 		 9782133119

rahulmehra571995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institute of Ayurved Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Chikitsa Chapter 4 Shloka 8, Procedure details: METHOD OF AGNIKARMA Purvakarma Before procedure informed written consent will be taken. Injection TT 0.5 CC Intramuscular will be given, if not taken in early 6 months. Whole procedure will be described to patient in detail and assured in their own language. Pradhankarma The Loha Shalaka will be heated to red hot over the flame of the heating device. The Staff Nurse will be advised to hold the affected area (posterior neck region, region of shoulder and arms) in suitable position. Later Agnikarma will be performed with Red Hot Shalaka in Binduakriti at mark points in such a way that Samyakdagdha lakshanas will be observed. Pashchatkarma The site will be cleaned with plain gauze piece. Same procedure will be done on 7,14,21 days upto 4 weeks/28 days for desirable results.) Duration of procedure: 28 days)
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Sushruta Sharira Chapter 6 Shloka 35, Procedure details: METHOD OF MARMA CHIKITSA Patient will be made to sit. Pressure will be made for 0.8 second (one cardiac cycle). It would be repeated for 18 to 20 times (normal respiration rate) (Frequency - 3 times a day) Kshipra, Talahridaya, Kurca, Kurcasira, Manibandha, Indravasti, Kurpara, Urvi, Ani Marma along with Krikatika and Amsa, Amsaphalaka of back, these marma points are selected to be stimulated for treatment of cervical spondylosis. Duration of Procedure: 28 days)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Diagnose cases of cervical spondylosis with symptoms like headaches, tingling/numbness, radiating pain to shoulders or arms, reduced sensation, difficulty in coordination. Sign of cervical spondylosis are neck pain, stiffness, limited movement, muscle weakness, numbness, balance issues, popping sensations. 
 
ExclusionCriteria 
Details  1. Severe or acute medical conditions eg: HIV, HbsAg, VDRL, etc.
2. Pregnancy
3. Open wounds or skin infections.
4. Fractures or severe skeletal injuries.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Marma chikitsa compared to Agnikarma in the pain
management of Cervical spondylosis (ws.r. to Greeva Sandhigata Vata).  		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Agnikarma in the pain
management of Cervical spondylosis (ws.r. to Greeva Sandhigata Vata) 		 28 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)   01/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Level of study : OPD/IPD 
 Study type : Interventional, Randomized comparative clinical 
 Method of Randomization : Simple random sampling 
 Purpose : Treatment 
 Timing : Prospective 
 End point : Efficacy 
 Number of groups : Two 
 Number of patients : 30 (15 patients in each group) 
 Duration of study : 28 days
30 patients will be randomly selected for the study. 
 Group A: Agnikarma in 15 patients. 
 Group B: Marma Chikitsa in 15 patients. 
Follow up will be done on 7th, 14th, 21th, and 28th day during treatment. 
 
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