| CTRI Number |
CTRI/2024/06/068711 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness of Mezhugu kalimbu (External therapy)in the management of varicose Ulcer
|
|
Scientific Title of Study
|
An open labelled non-randomized phaseII clinical trial to evaluate the effectiveness of Mezhugu kalimbu(External therapy)in the management of Narambu kiranthi (varicose Ulcer)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHINAKARAN T |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical College and hospital, palayamkottai |
| Address |
II year, Department of pura maruthuvam, Government siddha medical College and hospital, palayamkottai, Tirunelveli
dhinakarantm1998@gmail.com
8531851043
TAMILNADU
627002
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8531851043 |
| Fax |
|
| Email |
dhinakarantm1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S SUJATHA MDS |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government siddha medical College and hospital, palayamkottai |
| Address |
Department of pura maruthuvam, Government siddha medical College and hospital, palayamkottai, Tirunelveli
sujatharajasekar66@gmail.com
9442331462
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S SUJATHA MDS |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government siddha medical College and hospital, palayamkottai |
| Address |
Department of pura maruthuvam, Government siddha medical College and hospital, palayamkottai, Tirunelveli,627002
sujatharajasekar66@gmail.com
9442331462
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@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 DHINAKARAN T |
| Address |
II Year, Department of pura 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 T Dhinakaran |
Government siddha medical College and hospital, palayamkottai |
PG Department, Department of pura maruthuvam, Government siddha medical College and hospital, palayamkottai, Tirunelveli,627002
Tirunelveli
TAMIL NADU |
8531851043
dhinakarantm1998@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: I830||Varicose veins of lower extremities with ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mezhugu kalimbu |
External apply in affected area once a day for 15 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are willing to take external therapy alone
Patient who are willing for admission and stay in IPD or willing to attend OPD.
Patients who are willing to give blood samples for laboratory investigations. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Severe renal, hepatic, cardiac disease
Malignant ulcers
Uncontrolled diabetes
Syphilitic ulcers
Ischemic ulcers
Traumatic ulcers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.
|
15 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)
|
26/06/2024 |
| Date of Study Completion (India) |
27/08/2025 |
| Date of First Enrollment (Global) |
26/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is an open labelled non randomised phase II clinical trial to evaluate the effectiveness of MEZHUGU KALIMBU ( external therapy) in the management of NARAMBU KIRANTHI( varicose ulcer).This trial drug will be an external application for daily 15 days in 40 patients.The trial period of 24 moths will be carried out in government Siddha medical College and hospital, palayamkottai, Tirunelveli 627002, Tamilnadu,The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.In clase of any adverse events is noticed and it will be referred to pharmacovigilence department,and further management of patients will be given OPD patients.
|