| CTRI Number |
CTRI/2024/11/076854 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathy in treating Ringworm infections - A comparative questionnaire based study |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic medicines and Tuberculinum in Dermatophytosis and analyzing the quality of life using Dermatology Life Quality Index |
| Trial Acronym |
DLQI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Salini Maala |
| Designation |
Post Graduate Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem
Tamil Nadu
India
Salem
TAMIL NADU
636308
India |
| Phone |
6381016376 |
| Fax |
|
| Email |
dr.shalumathivanan47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Niruban Raj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem
Tamil Nadu
India
Salem
TAMIL NADU
636308
India |
| Phone |
9894821412 |
| Fax |
|
| Email |
nirubanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Niruban Raj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem
Tamil Nadu
India
Salem
TAMIL NADU
636308
India |
| Phone |
9894821412 |
| Fax |
|
| Email |
nirubanraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem Tamil Nadu 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem
Tamil Nadu
India |
| Type of Sponsor |
Private 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 M Salini Maala |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No: 3B - PG
Department of Homoeopathic Materia Medica
OPD Medical Unit II Ground floor
Sankari main road
NH 47 Chinnaseeragapadi P O
Salem
Tamil Nadu
India
Salem
TAMIL NADU |
6381016376
dr.shalumathivanan47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMKVMC&H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicines |
Individualized Homoeopathic medicines will be selected according to the totality of symptoms.
Single dose of selected medicine will be given at required intervals through oral route for a period of 6 months. |
| Comparator Agent |
Tuberculinum |
Homoeopathic preparations of Tuberculinum in different potencies obtained from standard GMP certified Homoeopathic medicine manufacturer.
Single dose will be given at required intervals through oral route for a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed of Tinea infection based on clinical signs and symptoms
Patients who test KOH positive |
|
| ExclusionCriteria |
| Details |
Patients with immune compromised state or on immune suppressive drugs
Patients having Cellulitis and Disseminated/Deep Dermatophytosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on clinical signs and symptoms of Dermatophytosis |
At baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Based on Dermatology Life Quality Index (DLQI) |
Day 1 and 2nd, 4th and 6th months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
27/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
All cases of Ringworm infection consulting in Vinayaka Missions Homoeopathic Medical college and Hospital will be subjected to a detailed case taking in a standardized case record formulated for the purpose. A Randomized Controlled study conducted in patients with both intervention and comparator group. Patient in the Intervention group will be administered Individualized homoeopathic medicines in appropriate dose and potency at required intervals. Patients in Comparator group will be administered Tuberculinum in different potencies and repeated at required intervals. As it is a comparative study, 30 cases in each group of both sexes will be selected. Quality of life will be assessed on day 1 and 2nd, 4th and 6th months of treatment using Dermatology Life Quality Index questionnaire. |