| CTRI Number |
CTRI/2024/07/071208 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
An Open Labelled Triple Arm Non Randomized Phase II Clinical Trial To Evaluate The Efficacy Of Siddhar Yoga Muraigal And Siddha Medicine Mavilangapattai Kudineer In The Management Of Kumba Vatham |
|
Scientific Title of Study
|
An open labelled triple arm non- randomised phase II clinical trial to evaluate the efficacy of Siddhar yoga muraigal and siddha medicine mavilangapattai kudineer in the management of Kumba vatham (Peri arthritis) |
| 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 R Rajesh |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical College and hospital |
| Address |
II year
PG Department of siddhar yoga maruthuvam,
Government Siddha Medical College and Hospital, Palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7904718196 |
| Fax |
|
| Email |
drrajeshraj94@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital Palayamkottai |
| Address |
PG Department of Siddhar Yoga Maruthuvam,
Government Siddha Medical College and Hospital Palayamkottai,
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital Palayamkottai |
| Address |
PG Department of siddhar yoga maruthuvam,
Government siddha medical College and hospital Palayamkottai,
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of government siddha medical College and hospital Palayamkottai Tirunelveli 627002 |
|
|
Primary Sponsor
|
| Name |
Dr R Rajesh |
| Address |
2nd year
Department of siddhar yoga maruthuvam
Government siddha medical College and hospital Palayamkottai
Tirunelveli
Tamil Nadu
India |
| Type of Sponsor |
Other [Self] |
|
|
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 R Rajesh |
Government siddha medical College and hospital |
II year
Department of Siddharth yoga maruthuvam
Government siddha medical College and hospital
Palayamkottai
Tirunelveli
627002
Tirunelveli
TAMIL NADU |
7904718196
drrajeshraj94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI 627002, Tamil Nadu, India |
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 |
| Comparator Agent |
Mavilangapattai kudineer |
30-50 ml twice a day internally for 48 days |
| Comparator Agent |
Siddhar yoga muraigal |
Balasana
Adho mukha savasana
Marjariasana
Bitilasana
Gomukhasana
Savasana
Yoga therapy for 48 days |
| Intervention |
Siddhar yoga muraigal with mavilangapattai kudineer |
Yoga therapy and mavilangapattai kudineer 30 -50 ml twice a day internally for 48 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Shoulder joint pain
Stiffness or heaviness of shoulder muscles
Idiopathic cause
History of diabetes mellitus
Patient who are willing for admission and stay in IPD or willing to attend OPD
Patient willing to sign informed consent document |
|
| ExclusionCriteria |
| Details |
Patient with uncontrolled hypertension
Pregnancy and lactation
Congenital anomalies
Patients with any other serious systemic illness
Patient who are having skin disease
History of trauma
Patient who face difficulties or hesitate to practice yoga are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims at bringing light on the efficacy of the long standing traditional practice of siddhar yoga muraigal and mavilangapattai kudineer towards the management of kumba vatham (peri arthiritis) |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The positive impact of yoga in the treatment aspect may be highlighted through this study |
48 days |
|
|
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 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="2"
Months="0"
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
|
This study is an open labelled Triple armed non-randomized phase II clinical trial to evaluate the
efficacy of
SIDDHAR YOGA MURAIGAL AND siddha medicine Mavilangapattai kudineer in the management of
Kumba vatham (peri arthritis)The study contain 3 groups and divided into Group I is siddhar yoga
Muraigal.Group II is mavilangapattai kudineer and Group III is siddhar yoga Muraigal and mavilangapattai kudineer .Each group contain 20 patients and duration 48 days.The study period is 24 months will be
carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002,
Tamilnadu.The outcome will be a positive impact of yoga therapy and medicine in the management of kumba vatham(peri arthritis).In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilence department of further management of patients will be given opd patients |