| CTRI Number |
CTRI/2025/05/086449 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Thipilliver Chooranam for Ringworm Fungal Infection |
|
Scientific Title of Study
|
Treatment of Tinea Corporis (Padarthamarai) with Thipilliver Chooranam A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhildhar T |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Room no S1, Department of PG General Medicine, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9790549422 |
| Fax |
|
| Email |
dhildharthamizuddin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chitra. U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Room no S1, Department of PG General Medicine, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chitra. U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Room no S1, Department of PG General Medicine, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research grant from CCRS (The Central Council for Research in Siddha), Central Council for Research in Siddha, Tambaram Sanatorium, GST Road, Chennai – 600 047, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
The Central Council for Research in Siddha |
| Address |
Central Council for Research in Siddha, Tambaram Sanatorium, GST Road, Chennai – 600 047, Tamil Nadu, India |
| Type of Sponsor |
Research institution |
|
|
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 Dhildhar |
Government Siddha Medical College and hospital |
Department of PG Pothu Maruthuvam, Room no S1, Arumbakkam, Chennai-600106
Chennai
TAMIL NADU |
9790549422
dhildharthamizuddin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Government Siddha Medical College Arumbakkam Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thipilliver Chooranam |
Thipilliver Chooranam is a powder form of siddha medicine. It will be taken from 500 mg to 1 g with honey, Thrice a day, after food for a period of 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have ringworm infection |
|
| ExclusionCriteria |
| Details |
1. Immunocompromised patients
2. Children, Adolescent Pregnant/ Lactating women
3. Patients who have history of hypersensitivity/ Allergy
4. Patients associated with other skin conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be based on the resolution of skin lesions. |
The outcome will be assessed after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be based on the absence of fungi on the skin in the KOH wet mount test. |
The outcome will be taken after 4 weeks of treatment. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0"
Months="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dhildharthamizuddin@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 01-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Tinea Corporis also known as ringworm, is a common fungal infection that affects the skin. The fungi causing Tinea Corporis persist on the skin for extended periods, making it challenging to fully eradicate with current treatment and leading to frequent relapses. Thipilliver Chooranam is a powder form of siddha medicine prescribed for ringworm fungal infection. |