| CTRI Number |
CTRI/2018/10/016065 [Registered on: 17/10/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homeopathic treatment of ringworm |
|
Scientific Title of Study
|
A Comparative Effectiveness Study of 50 Millesimal Potencies and Centesimal Potencies in the Treatment of Tinea Corporis: An Open, Randomized, Pragmatic Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-8309 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Hazra |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, Division 10 (PG 1), 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9681974966 |
| Fax |
|
| Email |
pallavihazra1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyamal Kumar Mukherjee |
| Designation |
Professor |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine, Division 10 (PG 1), 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyamal Kumar Mukherjee |
| Designation |
Professor, Department of Community Medicine |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine, Division 10 (PG 1), 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
DNDe Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, 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 |
| Pallavi Hazra |
D. N. De Homoeopathic Medical College & Hospital |
OPD room 1, Dept of Dermatology; 12, Gobinda Khatick Road, Kolkata- 700046
Kolkata
WEST BENGAL |
9681974966
pallavihazra1991@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homeopathic individualised medicines in 50 millesimal potencies |
Intervention is planned as
administering indicated
homeopathic medicines in 50 millesimal potencies. In 50 millesimal potencies, a single medicated cane sugar globule of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 90% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Dosage and repetition will be depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with the indicated medicines, all the patients will be advised to maintain local hygiene. Duration of therapy: 3 months |
| Intervention |
Homeopathic individualised medicines in centesimal potencies |
Intervention is planned as
administering indicated
homeopathic medicines in
centesimal potencies, as
decided appropriate to the case or condition. In centesimal scale, each dose shall consist of
6-8 globules (no. 10) of cane sugar, medicated with a single drop of 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. Along with the indicated medicine all the patients will be advised to maintain local hygiene. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of Tinea corporis, suffering for at least 3 months (ICD 10 B35.4)
2. Age 18-65 yrs
3. Both sexes
4. Literate patients who are able to read or write
5. Patient using topical agents for tinea lesions will be included after a washout period of two weeks |
|
| ExclusionCriteria |
| Details |
1. Cases with complications like lichenification and eczematisation
2. Similar looking skin conditions; e.g. seborrhic dermatitis, pityriasis rosea and some types of psoriasis
3. Patients who are too sick for consultation, unable to read patient information sheet, unwilling to take part or not giving consent to join the study
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 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
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 0-10 Numeric rating scale measuring intensity of itching |
At baseline, after 6 weeks and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skindex-29 questionnaire |
At baseline, after 6 weeks and after 12 weeks |
| Dermatological Life Quality Index (DLQI) questionnaire |
At baseline, after 6 weeks and after 12 weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The prevalence of superficial mycotic infection worldwide is 20-25% of which dermatophytes are the most common agents. Over the last few years, studies on epidemiology of dermatophytic infection from different part of India have shown a rising trend in the prevalence of cutaneous dermatophytosis with change in spectrum of infection and isolation of some uncommon species. 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. So here remains a scope of other non-invasive and alternative therapies including homeopathy for tinea infection that needs to be evaluated in terms of safety, effectiveness, and mechanisms. In this prospective, open, randomised, pragmatic, parallel arm trial at D. N. De Homoeopathic Medical College and Hospital, 60 patients suffering from tinea corporis will be randomised in 1:1 ratio into either individualised homeopathic medicines in centesimal potency or individualised homeopathic medicines in 50 millesimal potency. 0-10 numeric rating scale will be used as the as primary outcome, and Skindex-29 and DLQI will be used as the secondary outcome measures, measured at baseline, after 6 and 12 weeks. At the end of 3 months, comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |