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
|
|
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
|
|
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 ≥ 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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