| CTRI Number |
CTRI/2022/05/042413 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled double arm non randomized phase II clinical trail, To evaluate the efficacy of Siddhar yoga Maruthuva muraigal and siddha medicine PODUTHALAI KASHAYAM (Internal medicine) in the management of PERI ARTHRITIS |
|
Scientific Title of Study
|
"AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II,CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SIDDHAR YOGA MARUTHUVA MURAIGAL AND SIDDHA MEDICINE "PODUTHALAI KASHAYAM" IN THE MANAGEMENT OF "KUMBA VATHAM"(PERIARTHRITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B ARTHI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
II year PG scholar Department of Siddhar yoga Maruthuvam, Government Siddha medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9894460456 |
| Fax |
|
| Email |
arthiav24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S POONGODI KANTHIMATHI MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
Department of Siddhar yoga Maruthuvam,Government Siddha medical college and hospital, palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S POONGODI KANTHIMATHI MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
Department of Siddhar yoga Maruthuvam,Government Siddha medical college and hospital, palayamkottai
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha medical college and hospital palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr B ARTHI |
| Address |
II year PG scholar Department of Siddhar yoga Maruthuvam Government Siddha medical college and hospital palayamkottai Tirunelveli-627002 |
| 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 B ARTHI |
Government Siddha medical college and hospital palayamkottai |
II year PG scholar Department of Siddhar yoga Maruthuvam Government Siddha medical college and hospital palayamkottai Tirunelveli-627002
Tirunelveli
TAMIL NADU |
9894460456
arthiav24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
| Comparator Agent |
PODUTHALAI KASHAYAM ( Internal medicine) |
30 - 50 ml twice a day for 48 days |
| Intervention |
Siddhar yoga Maruthuva muraigal with PODUTHALAI KASHAYAM ( Internal medicine) |
Yoga therapy for 48 days and PODUTHALAI KASHAYAM 30 - 50 ml twice a day internally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age : Between 18-16 years
2. Sex : Both male and female
3. Shoulder joint pain
4. Stiffness or heaviness of shoulder muscles
5. Idiopathic cause
6. History of diabetes mellitus
7. Patient who are willing for admission and stay in IPD or willing to attend OPD
8. Patient willing to sign informed consent document. |
|
| ExclusionCriteria |
| Details |
1. Age : Below 18 years and above 60 years
2. Patient who face difficulties or hesitate to practice yoga are excluded.
3. Patient with uncontrolled hypertension
4. Pregnancy and lactation
5. Congenital anomalies
6. Patient with any other serious systemic illness
7. Patient who are having the skin disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreases the intensity of pain reduce swelling of joints |
Decreases the intensity of pain reduce swelling of joints within 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/05/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open labelled double arm non randomized phase II clinical trail To evaluate the efficacy of Siddhar yoga Maruthuva muraigal and siddha medicine PODUTHALAI KASHAYAM (internal medicine) in the management of KUMBA VATHAM. PODUTHALAI KASHAYAM DOSAGE : 30 - 50 ml twice daily Along with Siddhar yoga Maruthuva muraigal |