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CTRI Number  CTRI/2020/08/027350 [Registered on: 24/08/2020] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha
Other (Specify) [Varmam]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Siddha Varmam therapy for the treatment of shoulder pain and disability. 
Scientific Title of Study   A single center randomized parallel group clinical trial to compare the efficacy of Siddha Varmam Therapy and Thailam Application (SVT) versus Thailam Application (TA) in terms of pain and disability in the treatment of Kumbavatham (Adhesive capsulitis)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MEENA R  
Designation  RESEARCH OFFICER (SIDDHA) 
Affiliation  Siddha Central Research Institute 
Address  Anna hospital campus, Anna arch.Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  meenaprakashphd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MEENA R  
Designation  RESEARCH OFFICER (SIDDHA) 
Affiliation  Siddha Central Research Institute 
Address  Anna hospital campus, Anna arch.Arumbakkam


TAMIL NADU
600106
India 
Phone    
Fax    
Email  meenaprakashphd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MEENA R  
Designation  RESEARCH OFFICER (SIDDHA) 
Affiliation  Siddha Central Research Institute 
Address  Anna hospital campus, Anna arch.Arumbakkam


TAMIL NADU
600106
India 
Phone    
Fax    
Email  meenaprakashphd@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Siddha 
 
Primary Sponsor  
Name  Central Council for Research in Siddha 
Address  Anna hospital campus, Anna arch, Arumbakkam, Chennai-600106 
Type of Sponsor  Research institution 
 
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 S Natarajan  Siddha Central Research Institute  Anna hospital Campus, Anna arch, Arumbakkam, Chennai- 600106
Chennai
TAMIL NADU 
9843086050
044-26214809
dcr.scri@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Human 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Siddha Varmam Therapy and Thailam application  The group will be given Varmam therapy and Vatha kesari thailam application. Treatment duration:3 days in a week for 6 weeks, ie 18 visits.  
Comparator Agent  Thailam application  Application of Vathakesari thylam alone. Treatment duration:3 days in a week for 6 weeks, ie 18 visits.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with shoulder pain > 70% SPADI lasting for more than a month and range of motion limited at least 25% in one or more directions measured using Goniometer.
2.Duration of complaints > 3 months 
 
ExclusionCriteria 
Details  1.History of Rotator tear, traumatic history, history of surgery in shoulder joint in the preceding 1 year, patients who underwent Varmam treatment/any other external treatment for kumbavatham within last three months prior to enrolment, history of fracture in clavicle, humerus, scapula and bones of upper limbs, osteoarthritis shoulder, Cervical neuropathy, paralysis, neurological disorder, shockwave or injection therapy in shoulder joint, Ischemic Heart Disease, rheumatoid arthritis, dislocation, osteoporosis, lifting heavy weight in routine life, pregnancy, lactation.
2.Intervention model: parallel assignment.
3.Arms: 2 (Experimental arm-2)
4.Experimental arm 1: Thailam Application.
5.Experimental arm 2: Varmam + Thailam Application.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• Reduction in shoulder pain and improvement in range of movements of shoulder joint. It is assessed by Shoulder Pain and Disability Index – SPADI.  Screening, At the time of recruitment, End of the trial period. Time point: 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
• Quality of life of trial participants. It will be assessed by Quality of life questionnaire. (SF-36 questionnaire).

• End point classification: SPADI, SF-36, Safety Parameters.
• Time schedule of enrolment: 18 months. Project duration: 3 years.
• Treatment duration: 3 days in a week on alternate days for 6 weeks, ie 18visits
 
At the time of recruitment and at the end of the trial period.
Time point: 6 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   23/07/2021 
Date of Study Completion (India) 30/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Study not initiated 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

    This study is a randomized parallel group clinical trial which compares the efficacy of Siddha Varmam therapy and Thailam application with that of Thailam application in Kumbavatham patients. i.e, adhesive capsulitis. The thailam used is Vatha kesari thylam. Varmam points employed are those mentioned in the text ’Guidelines for practice of Siddha Varmam therapy, 1st Edition, 2017, Central Council for Research in Siddha, Ministry of AYUSH, Govt. of India’ . Patients aged between 35 years to 65 years with shoulder pain ( >=70% by SPADI) lasting for more than a month and range of motion limited by at least 25% in one or more directions measured using Goniometer. Male, female and transgender patients having complaints â‰¥ 3 months will be enrolled. Patients having history of Rotator tear, traumatic history, history of surgery in shoulder joint in the preceding 1 year, patients who underwent Varmam treatment/any other external treatment for kumbavatham within last three months prior to enrolment, history of fracture in clavicle, humerus, scapula and bones of upper limbs, osteoarthritis shoulder, Cervical neuropathy, paralysis, neurological disorder, shockwave or injection therapy in shoulder joint, Ischemic Heart Disease, rheumatoid arthritis, dislocation, osteoporosis, lifting heavy weight in routine life, pregnancy, lactation will be excluded. The pain and disability will be assessed by SPADI and the quality of life will be assessed using SF -36 questionnaire. The study centre is Siddha Central Research institute, Chennai. The adverse events if any will be informed to the pharmacovigilance cell of SCRI. The trial duration is 6 weeks and the patients will be instructed to come 3 days in a week  on alternate days. They will be followed up for 2 weeks. Seperatedata collection forms will be used for data collection. Appropriate statistical methods will be used for data analysis. The outcome of the study will be published in a peer reviewed journal. 



 
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