| CTRI Number |
CTRI/2025/08/093480 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicine for patients with ringworm of the body. |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of tinea corporis in adults: A double-blind, randomized, placebo-controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-0068 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nafisa Khatun |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
8617300530 |
| Fax |
|
| Email |
nafisakhatun062@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nafisa Khatun |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
8617300530 |
| Fax |
|
| Email |
nafisakhatun062@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
| 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 Nafisa Khatun |
D N De Homoeopathic Medical College and Hospital |
Dept. of Repertory, OPD 9 (Skin), and PG 3, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
8617300530
nafisakhatun062@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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 |
Identical looking placebo plus Concomitant care |
This arm will be administered a placebo. The placebo is identical to the verum in its physical appearance. Each dose of placebo will consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be administered orally on a clean tongue with an empty stomach; the dosage and repetition will depend upon the individual requirements of the cases. Both medicines and placebo will be re-packed in identical glass bottles and labelled with code, name of medicine, and potency, and will be dispensed according to the random number list.
Concomitant care (CC): All enrolled patients will receive general management advice, such as applying olive oil, or coconut oil externally twice daily, depending on the financial situation, keeping the area dry, avoiding tight clothing, including synthetic clothing, and washing the bed linens and infected clothing separately in hot water. Duration of care: 2 months. |
| Intervention |
Individualized homoeopathic medicines plus Concomitant care |
The planned intervention involves administering indicated homeopathic medicines in centesimal potencies (CH). Each dose consists of 4 globules (no. 30) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be administered orally on a clean tongue and an empty stomach; dosage and repetition will depend on the individuals requirements in each case. Patients will be instructed to avoid handling the globules and to refrain from eating, drinking, smoking, or brushing their teeth for 30 minutes after taking the globules. They will be advised to suck on the globules instead of just swallowing them. On each occasion, an individualized approach to medicine will be prescribed, taking into consideration the totality of presenting symptoms, detailed clinical history, constitutional features, miasmatic expressions, and repertorization through HOMPATH/RADAR software as necessary, together with a thorough consultation of the Materia Medica and consensus among three homeopaths. All medicines and other items will be sourced from a firm that maintains Good Manufacturing Practice (GMP) certification.
Concomitant care (CC): All enrolled patients will receive general management advice, such as applying olive oil, or coconut oil externally twice daily, depending on the financial situation, keeping the area dry, avoiding tight clothing, including synthetic clothing, and washing the bed linens and infected clothing separately in hot water. Duration of care: 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from tinea corporis (1F21.1 ref. ICD11) for 3 months or more, diagnosis confirmed through KOH mount test.
2.Age between 18 and 65 years
3.Patients of either sex or transgender.
4.Patients previously treated with topical antifungal agents will be eligible for enrolment following a minimum washout period of seven days.
|
|
| ExclusionCriteria |
| Details |
1.Patients with complications such as lichenification or eczematization.
2.Skin conditions that mimic tinea, such as seborrheic dermatitis, pityriasis rosea, and psoriasis.
3.Individuals who are too unwell for consultation, unable to comprehend the patient information sheet, or unwilling to participate.
4.Diagnosed cases of other systemic disease i.e., uncontrolled diabetes or life-threatening illness affecting quality of life, or any organ failure.
5.Vulnerable groups include unconscious, non-ambulatory, critically or terminally ill patients, differently abled individuals, and those with mental incompetence.
6.Pregnant, postpartum, or lactating women.
7.Individuals with a history of tobacco use (chewing or smoking), alcohol dependency, or any form of substance abuse (TAPS tool) [36].
8.Self-reported immunocompromised individuals, AIDS, hepatitis, etc.
9.Patients who have received homeopathic treatment for a chronic illness within the last six months.
10.Simultaneous participation in any other clinical activity.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skindex-29 questionnaire |
At baseline, monthly, up to 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 5- D Pruritus Scale |
At baseline, monthly, up to 2 months |
| Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) |
At baseline, monthly, up to 2 months |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nafisakhatun062@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Superficial mycotic infections affect approximately 20–25% of the global population, with dermatophytes being the most common causative agents. Tinea is characterized by slow-growing lesions that frequently have some central clearance (ring-like). In certain people, the fungus causes virtually minimal inflammation; in these patients, the infection manifests as a marginated area of rough, scaling skin. Treatment typically involves topical antifungals for mild cases, while more extensive infections often require systemic therapy. In recent years, chronic dermatophyte infections have become increasingly common and challenging to treat. However, the absence of updated national or international guidelines for managing tinea corporis, tinea cruris, and tinea pedis has led to largely empirical systemic antifungal treatments [3]. Homeopathy may have immense potential to offer in the successful treatment of tinea corporis, but concrete data is not available for this claim. Under such circumstances, we intend to undertake this research project to evaluate the Efficacy of individualized homoeopathic medicines in the treatment of tinea corporis in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 108 adults who are suffering from tinea corporis at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by the Skindex-29 questionnaire [Primary outcomes], 5-D pruritus scale, and MYMOP-2 (Measure Yourself Medical Outcome Profile) [Secondary outcomes] every month up to 2 months. Comparative analysis will be carried out to detect group differences.
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