| CTRI Number |
CTRI/2026/02/104637 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF THAZHUTHALAI KATTU (BANDAGE IN SIDDHA EXTERNAL THERAPY) IN THE MANAGEMENT OF KUMBAVATHAM (PERIARTHRITIS OF SHOULDER JOINT) |
|
Scientific Title of Study
|
AN OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF THAZHUTHALAI KATTU (BANDAGE IN SIDDHA EXTERNAL THERAPY) IN THE MANAGEMENT OF KUMBAVATHAM (PERIARTHRITIS OF SHOULDER JOINT) |
| 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 VIGNESHWARAN R |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,No 2, LANGAR GANA STREET ,PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7094090960 |
| Fax |
|
| Email |
vigneshwaranraja007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GANESAN G MDs |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
LECTURER, DEPARTMENT OF PURA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GANESAN G MDs |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
LECTURER, DEPARTMENT OF PURA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICALCOLLEGE AND HOSPITAL, PALAYAMKOTTAI |
|
|
Primary Sponsor
|
| Name |
DR VIGNESHWARAN R |
| Address |
PG SCHOLAR,DEPARTMENT OF PURA MARUTHHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGA
GANA STREET, PALAYAMKOTTAI,TIRUNELVELI,TAMIL NADU,INDIA 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 VIGNESHWARAN R |
GOVERNMENTSIDDHA MEDICALCOLLEGE AND HOSPITAL,PALAYAMKOTTAI. |
PG SCHOLAR,DEPARTMENT OF PURA
MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL,627002
COLLEGE AND HOSPITAL,NO 2 LANGAR GANA
STREET,PALAYMKOTTAI
Tirunelveli
TAMIL NADU
Tirunelveli
TAMIL NADU |
7094090960
Vigneshwaranraja007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
THAZHUTHALAI KATTU [BANDAGE IN EXTERNAL THERAPY] |
THAZHUTHALAI KATTU [BANDAGE IN EXTERNAL THERAPY] -12 TO 15 HRS/THREE DAYS ONCE FOR 21 DAYS |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pain in Shoulder joints
Stiffness or heaviness of shoulder joint
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 |
1. History of Trauma in shoulder joint/ surgery
2. Posterior glenohumeral dislocation
3. Rotator cuff injury
4. Subacromial rotator cuff impingement
5. Proximal biceps tendonitis
6. Acromioclavicular joint Arthrosis
7. Cervical spine neuropathy
8. Hyperthyroidism and Hypothyroidism
9. Pregnant women and Lactating mothers
10. Patients with any other serious systemic illness
11. Patient who are having the skin ailments . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help To evaluate the improvement of clinical signs and symptoms of Kumbavatham
(Periarthritis of shoulder joint ) patients before and after treatment of Thazhuthalai Kattu
(Bandage in Siddha external therapy). |
This study will help To evaluate the improvement of clinical signs and symptoms of Kumbavatham
(Periarthritis of shoulder joint ) patients before and after treatment of Thazhuthalai Kattu
(Bandage in Siddha external therapy) For 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Siddha & modern parametric changes during trial period.
To assess safety profile of the trial medicine
To analyze the line of treatment in Kumbavatham (Periarthritis of shoulder joint). |
21 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/03/2026 |
| 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="6"
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
|
IT IS AN OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRAIL TO EVALUATE THE EFFECTIVENESS OF THAZHUTHALAI KATTU
TRAIL DRUG: THAZHUTHALAI KATTU CONSISTS OF LEAVES OF THAZHUTHALAI (CLERODENDRUM PHLOMIDIS) , NOTCHI (VITEX NEGUNDO) , VADHAMADAKKI (DELONIX ELATA).
EXTERNAL THERAPY: KATTU [BANDAGE ]
TRAIL PROCEDURE: Clerodendrum phlomidis (Thazhuthalai), Vitex negundo(Notchi), Delonix elata(Vadhamadakki) leaves are boiled in water and the steam is applied on the affected shoulder joint , then the boiled leaves are used for compress after application of castor oil in shoulder joint. |