| CTRI Number |
CTRI/2024/05/067408 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy) in the management of Azhal keel vayu |
|
Scientific Title of Study
|
An open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee 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 |
DrRAnand |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical College and hospital, Palayamkottai. |
| Address |
II year pg scholar Department of Pura maruthuvam, Government siddha medical College and hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778393674 |
| Fax |
|
| Email |
anandimmanuel98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGGanesan MDS |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical College and hospital, Palayamkottai |
| Address |
Department of pura maruthuvam, Government siddha medical College and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSSujatha MDS |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical College and hospital, Palayamkottai. |
| Address |
Department of pura maruthuvam, Government siddha medical College and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government siddha medical College and hospital,Palayamkottai, Tirunelveli, tamilnadu,627002 |
|
|
Primary Sponsor
|
| Name |
Dr R Anand |
| Address |
II year pg scholar Department of Pura maruthuvam Government siddha medical College and hospital Palayamkottai Tirunelveli,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 R Anand |
Government siddha medical college and Hospital |
Pg department of Pura Maruthuvam Government siddha medical College and hospital palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU |
8778393674
anandimmanuel98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kalvaazhai kattu |
This medicine was applied over the knee as compressive bandage.This procedure are usually given for one time in a day at an interval of 3-7 days upto 3-7 kattu for 21 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of
1.Pain in single or both knee joints
2.Swelling
3.Tenderness
4.Stiffness
5.Crepitation
6.Restricted movements
Patients who are willing to undergo Kattu (Bandage in siddha external therapy)
Patients who are willing to give specimen of blood for investigation whenever required.
Patients who are willing to attend OPD or admission in IPD for 21 days.
Patients who are willing to take photograph before and after treatment.
Patients who are willing to take external therapy along.
|
|
| ExclusionCriteria |
| Details |
History of tuberculosis
History of hepatitis B,AIDS,Syphilis.
History of Haemophilia & anticoagulant treatment.
Rheumatoid and other types of arthritis.
Trauma, fracture,ligament injury.
History of psychiatric disorder.
Surgery of the affected knee joint during the previous 3 month or joint replacement. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of joint pain,stiffness and improvement in joint movements,physical functioning and quality of life |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2024 |
| Date of Study Completion (India) |
05/07/2025 |
| Date of First Enrollment (Global) |
26/05/2024 |
| 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
Modification(s)
|
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 was an open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee joint).The trail drug procedure will be given for one time in a day at an interval at an 3-7 days upto 3-7 Kattu for 21 days in 40 patients.The trial drug will be carried out in Government siddha medical College and hospital, palayamkottai,Tirunelveli 627002.The outcome will be Reduced severity of joint pain,Stiffness and improvement of joint movements and quality of life.In case of any adverse events was noticed and it will be referred to pharmacovigilence department.Further management of patients will be given OPD. |