| CTRI Number |
CTRI/2021/02/031442 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
22/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy in ringworm |
|
Scientific Title of Study
|
Evaluating feasibility of a double-blind, randomized, placebo-controlled trial of
individualized homeopathic medicines in tinea corporis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1264-6240 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Subhasish Ganguly |
| Designation |
Professor and Head, Dept. of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
ganguly.subhasish@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
|
Source of Monetary or Material Support
|
| 12, Gobinda Khatick Road, Tangra,
Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 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 |
| Prof Dr Subhasish Ganguly |
D. N. De Homoeopathic Medical College and Hospital |
Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
9007263548
ganguly.subhasish@rediffmail.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: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homeopathic medicines |
It is planned as administering
indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar,
medicated with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on clean tongue with empty
stomach; dosage and repetition
depending upon the individual
requirement of the cases. All
medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration of medicine: Oral. All the patients will be given general advices on external application of olive oil twice a day. Duration of therapy: 2 months |
| Comparator Agent |
Placebo |
Placebo, identical in
appearance with and
indistinguishable from the
medicine. Each dose of placebo
shall consist of 4 globules (no.30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and
repetition depending upon the
individual requirement of the
cases. All sundry items will be procured from a Good
Manufacturing Practice
(GMP)-certified firm. Route of
administration: Oral. All the patients will be given general advices on external application of olive oil twice a day. Duration of therapy: 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 (2020 ICD-10-CM diagnosis code B35.4) since last 3 months
2. Age 18-65 years
3. Patients of either sex
4. Patient using topical agents for tinea lesions will be included after a washout period of two weeks
5. Patients who are literate and capable of filling the questionnaire and providing
written informed consent |
|
| ExclusionCriteria |
| Details |
1. Cases with complication like lichenification and eczematisation
2. Similar looking skin conditions; e.g. seborrhic dermatitis, pityriasis rosea and psoriasis
3. Patients who are too sick for consultation
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled
or life-threatening illness affecting quality of life or any organ failure
5. Pregnant and puerperial women and lactating mothers
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state, and
8. Already undergoing homeopathic treatment for chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of patients in each group showing complete disappearance of the
skin lesions |
At baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intensity of pruritus measured by 0-10 numeric rating scales |
At baseline and after 2 months |
| Skindex-29 scores |
At baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
24/02/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published |
|
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
Response - Clinical Study Report
Response - Analytic Code
- 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 - Data are available indefinitely at (Link to be included www.dndeofficial.org/).
- For how long will this data be available start date provided 01-12-2021 and end date provided 30-11-2026?
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
|
The prevalence of superficial mycotic infection worldwide is 20-25% of which dermatophytes are the most common agents. Due to the lack of updated national or international guidelines on the management of tinea corporis, cruris, and pedis, treatment with systemic antifungals is often empirical. Although there is sufficient evidence to demonstrate the efficacy of topical antifungals in limited disease yet, there is scarce data on the frequency of relapse once topical monotherapy is discontinued. Though homeopathy is a popular choice among the patients, but peer-reviewed researches in tinea infection has remained seriously compromised. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 34 patients suffering from tinea corporis will be randomized to receive either individualized homoeopathic medicines (verum; n=17) or identical-looking placebo (control; n=17). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homoeopathy and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Number of patients in each group showing complete disappearance of the skin lesion, intensity of pruritus measured by 0-10 numeric rating scales (NRS) and Skindex-29 scores will be used as the primary and secondary outcome measures. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |