| CTRI Number |
CTRI/2025/04/085668 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on pancha lavana mezhugu in the management of AZHAL KEEL VAAYU (OSTEOARTHRITIS) |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of Pancha Lavana Mezhugu in the management of Azhal Keel Vaayu (Osteoarthritis of knee) |
| 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 A Silambarasan |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870519611 |
| Fax |
|
| Email |
simbuarjun02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash Chandran |
| Designation |
Associate professor |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9345600723 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Subash Chandran |
| Designation |
Associate professor |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9345600723 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of Government Siddha Medical College and Hospital, Tiruvanathapuram main road, Palayamkottai-627002, Tirunelveli, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002,Tamilnadu, India. |
| Type of Sponsor |
Government medical college |
|
|
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 A Silambarasan |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627002
Tirunelveli
TAMIL NADU |
8870519611
simbuarjun02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pancha lavana mezhugu |
Dosage 0.6 to 1.2 gram twice a day orally After food for 40 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Presenting with joint pain
2.Morning stiffness for less than 30 minutes
3.Crepitus on active movement
4. Joint line tenderness
5. Difficulty in range of motion
6. Patients Presenting with or without swelling |
|
| ExclusionCriteria |
| Details |
1. Patients with history of trauma and post trauma
2. Ligament tear
3. Patients undergone knee replacement surgery
4. Metabolic joint disease
5. Infectious joint disease
6. Inflammatory arthritis (RheumatoidArthritis)
7. Septic arthritis
8. Osteomyelitis
9. Chronic liver and renal disease
10. Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be aimed at reducing the symptoms of AZHAL keel vaayu
And to determine the effectiveness of pancha lavana mezhugu. |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To collect various aspects of AZHAL keel vaayu in Siddha literature
2.to evaluate siddha parameters (including Envagai thervu) changes and thegi in azhal keel vaayu during the study period
3. To document Bio statistical analysis. |
6 months |
|
|
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)
|
30/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is A PROSPECTIVE OPEN LABELLED, SINGLE ARM NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF PANCHA LAVANA MEZHUGU IN THE MANAGEMENT OF AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The trail drug PANCHA LAVANA MEZHUGU is freshly prepared and will be administrated at the dosage of 0.6 to 1.2g twice a day with hot water for 40 days. The trail period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627002,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of the trail drug PANCHA LAVANA MEZHUGU. The secondary outcome will be the evaluation of siddha diagnostic parameters(including envagai thervu) changes and thegi in azhal keel vaayu during the study period and collect various aspects of azhal keel vaayu in Siddha literature. |