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CTRI Number  CTRI/2021/08/036057 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 26/08/2021
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 Avabahuka (Frozen shoulder) 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY ON MARMA CHIKITSA AND AGNIKARMA(SNEHADAGDHA) IN THE MANAGEMENT OF AVABAHUKA W.S.R. TO FROZEN SHOULDER 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ANITA KANTWA 
Designation  M. S. Scholar 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur
KAILASH, TEH. - DANTARAMGARH
Sikar
RAJASTHAN
313001
India 
Phone  9672389497  
Fax    
Email  anuu17choudharyy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mahesh Dixit 
Designation  Professor 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ANITA KANTWA 
Designation  M. S. Scholar 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur
KAILASH, TEH. - DANTARAMGARH
Sikar
RAJASTHAN
313001
India 
Phone  9672389497  
Fax    
Email  anuu17choudharyy@gmail.com  
 
Source of Monetary or Material Support  
MADAN MOHAN MALVIYA GOVERNMENT AYURVED COLLEGE UDAIPUR 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Type of Sponsor  Other [Govt. Ayurved 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 
Prof Mahesh Dixit  M.M.M.Govt. Ayurved College Udaipur  OPD Room No. 1,PG Department of Shalya Tantra Govt. Ayurved Hospital , Madan Mohan Malviya Govt. Ayurved College, Udaipur
Udaipur
RAJASTHAN 		 9414245459

prof.maheshdixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, M.M.M. 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:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: FROZEN SHOULDER, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushrut samhita, Procedure details: Sneha dagdha from Guda, Madhu and Ghrita over the affected shoulder region one times daily for two weeks.)
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Sushruta samhita, Procedure details: Stimulation or rhythm of stimulation by pressure approx 18-20 times per minute on Hastha-kshipra, Kurpara, Kakshadhara and Amsa marma once daily for two weeks)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient suffering from Avabahuka(Frozen shouder) irrespective to demographic data.
2.Typical clinical features pertaining to the frozen shoulder like:-
- Pain - Stiffness - Restricted Active range of motion(AROM, Passive range of motion(PROM)- Tenderness
3. Patient willing to undergo trial

 
 
ExclusionCriteria 
Details  - Age below 20 year and above 60 year
- Not willing to undergo trial
- Pregnancy
- Uncontrolled Diabetes Mellitus
- HIV, HBsAg positive patients
- Suffering from tubercular arthritis,
osteoarthritis, gouty arthritis, and some
other joint pathology.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pain in shoulder joint
2.Stiffness in shoulder Joint
3.Range of Movements
•Inability to do daily routine work.

 		 6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To return back their routine life and occupational activities  6 weeks 
 
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   Phase 2 
Date of First Enrollment (India)   01/09/2021 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is the comparative clinical trial.
To study the efficacy of Agnikarma in the management of Avabahuka.
To evaluate the clinical efficacy of Marma therapy in Avabahuka.
To study the Avabahuka and Frozen Shoulder in both Ayurvedic and Modern context.
To provide safe, effective and unique treatment.
 
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