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CTRI Number  CTRI/2023/07/054820 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 05/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Other (Specify) [Marma stimulation by hand and TENS]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparitive evaluation of marma (vital points) pressing by hand and marma pressing by tens( a machine) in avabahuka(stiffness & pain in shoulder) wsr to frozen shoulder. 
Scientific Title of Study   A comparitive evaluation of marma stimulation by hand and marma stimulation by tens ( transcutaneous electrical nerve stimulation) in avabahuka wsr to frozen shoulder. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragati Bhutani 
Designation  Pg Scholar 
Affiliation  shri krishna government ayurvedic college and hospital, Kurukshetra (haryana) 
Address  Room no . 103, Pg Department of Shalya Tantra , Shri Krishna Government Ayurvedic College And Hospital, Kurukshetra (haryana)

Kurukshetra
HARYANA
136118
India 
Phone  7015346376  
Fax    
Email  prachibhutani22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anamika 
Designation  Assistant Professor  
Affiliation  shri krishna government ayurvedic college and hospital, Kurukshetra (haryana 
Address  Room no . 103, Pg Department of Shalya Tantra , Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra (haryana)

Kurukshetra
HARYANA
136118
India 
Phone  9896873083  
Fax    
Email  dranamikashalyavida@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pragati Bhutani 
Designation  Pg scholar 
Affiliation  Shri Krishna government ayurvedic college and hospital kurukshetra  
Address  Room no . 103, Pg Department of Shalya Tantra , Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra (haryana)

Kurukshetra
HARYANA
136118
India 
Phone  7015346376  
Fax    
Email  prachibhutani22@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna government ayurvedic college and hospital kurukshetra haryana 
 
Primary Sponsor  
Name  shri krishna government ayurvedic college and hospital, Kurukshetra (haryana 
Address  shri krishna government ayurvedic college and hospital,sector-8 umri road Kurukshetra (haryana) 
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 
Pragati Bhutani  Shri krishna government ayurvedic college and hospital  Room No. 14, OPD of shalya tantra, Shri krishna government ayurvedic college and hospital, Sec 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA 		 7015346376

prachibhutani22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Tiwari M, Khanna V, Maddhesia G, et al.Role and efficacy of TENS versus SWD inthe management of periarthritis shoulder.Indian J Orthop Surg 2015; 1: 211–214, Procedure details: TENS Electrodes will be placed on Talahridya, Kshipra, Manibandha, Indrabasti, Kurpara, Ani, Urvi, Kakshadhara, Ansa Marmas with the frequency of 100 Hz for 15-20 Minutes daily for 7 days)
2Comparator ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Negi Vineeta Kumari, 1Nariyal Vikas, 2Sharma Om Raj and 3Sharma S. K., Marma therapy in avabahuka (frozen shoulder): a retrospective cohort, wjpr, 2018; 7(19), Procedure details: Marma stimulation by hand on Talahridya, Kshipra, Manibandha, Indrabasti, Kurpara, Ani, Urvi, Kakshadhara, Ansa Marmas for 15-20 minutes daily for 7 days)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a. Patients having the typical sign and symptoms of Avabahuka:-
i. Amsa Shoola (pain in shoulder region)
ii. Bahupraspanditahara (limited range of motion of the upper limb)
b. Patients with controlled Diabetes Mellitus.
c. Patients willing to under go trial. 
 
ExclusionCriteria 
Details  a. Age below 30 years and above 60 years.
b. Suffering from specific arthritis like OA, RA etc.
c. Patients of shoulder joint dislocation/fracture or has the history for the same.
d. Patients having any previous surgical procedure of shoulder.
e. Co-existence of lesions to rotator cuff, sub acromial bursitis, cervical spondylosis leading shoulder pain.
f. Patients suffering from major systemic disorders e.g. IHD, Gout, SLE etc.
g. Patients having pacemaker or angiography done.
h. Malignant and Immuno-compromised patients (AIDS), HBsAg.
i. Patients with uncontrolled Diabetes Mellitus.
j. Pregnant women and lactating mothers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in subjective & objective parameters in patient from both group will be analaysed.  Almost 20 minutes per day for a week 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of stimulation of Marma points by hand in the management of Avabahuka Roga.
To study the effect of electrical stimulation on Marma points using TENS in the management of Avabahuka Roga.
To compare the efficacy of Marma stimulation by hand & electrical stimulation using TENS in the management of Avabahuka Roga . 		 1 year & 10 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   14/07/2023 
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="2"
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   Frozen shoulder or Adhesive capsulitis is a disease of shoulder joint. In which the shoulder capsule, connective tissue surrounding the glenohumeral joint of the shoulder becomes inflamed and stiff, greatly restricting motion and causing chronic pain. It causes problem in day-to-day activity and is not much studied yet. In ayurveda, it is compared with Avabahuk. So, there are some Marma points in the shoulder and the arm region. By stimulating these points by TENS therapy and Marma therapy by hand, this could be treated. In this study, two groups (30 patients each) will be made, one group will be treated by TENS therapy and other is by hand therapy on Marma. Then we will analyze the effect of both treatment and also compare their efficacy. The result will be analyzed by applying proper statistical method. 
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