| CTRI Number |
CTRI/2019/11/021999 [Registered on: 14/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2019 |
| 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 medicines for ringworm |
|
Scientific Title of Study
|
Efficacy of individualized homeopathic medicines in tinea corporis: double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1242-0070 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bakibillah Laskar |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9064304443 |
| Fax |
|
| Email |
blaskar113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swapan Paul |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapan Paul |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 13, Block GE, Sector III, Salt Lake
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt
Lake, Kolkata 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India |
| 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 |
| Bakibillah Laskar |
National Institute of Homoeopathy |
Dept. of Materia
Medica, OPD room no. 13, Block GE, Sector III, Salt Lake
Kolkata
Kolkata
WEST BENGAL |
9064304443
blaskar113@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in 50 millesimal potencies, as decided appropriate to the case or condition |
Intervention is planned as administering individualized homeopathic medicines in 50 millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, a single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 80 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be 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 from the cup. Medicines are required to be taken orally on clean tongue with empty stomach. All medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) - certified firm. Along with medicines, the intervention arm will receive advice on general management (i.e. external application of olive oil twice a day). Duration of therapy: 3 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
This arm will receive placebo, indistinguishable from verum. In 50 millesimal scale, a single non-medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 80 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be 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 from the cup. This will be instructed to be taken orally on clean tongue with empty stomach. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Along with medicines, the intervention arm will receive advice on general management (i.e. external application of olive oil twice a day). Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from tinea corporis since last 3 months
2. Age 18-65 years
3. Both sexes
4. Literate patients; ability to read English and/or Bengali
5. Providing written informed consent
6. Patient using antifungal agents for tinea lesions will be included after a washout period of four weeks |
|
| 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, 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, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients in each group showing complete disappearance of the skin lesion over 3 months of intervention |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intensity of pruritus measured by 0-10 numeric rating scales |
Baseline, every month, up to 3 months |
| Skindex-29 questionnaire |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 |
|
Date of First Enrollment (India)
|
18/11/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
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. Recent developments in understanding the pathophysiology of dermatophytosis have confirmed the central role of cell-mediated immunity in countering these infections. Hence, a lack of delayed hypersensitivity reaction in presence of a positive immediate hypersensitivity response to trichophytin antigen points toward the chronicity of disease. Management involves the use of topical antifungals in limited disease, and oral therapy is usually reserved for more extensive cases. The last few years have seen a significant rise in the incidence of chronic dermatophyte infections of skin which have proven difficult to treat. However, 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. Homeopathy peer-reviewed research in tinea infection has remained seriously compromised. We intend to uptake a randomized trial to explore any specific effect of individualized homeopathic medicines beyond placebo in tinea corporis using valid outcomes. In this double-blind, randomized, placebo-controlled trial, 62 patients suffering from tinea corporis will be randomized in 1:1 ration to either individualized homeopathic medicines in 50 millesimal potencies (n=31) or identical looking placebo (n=31). Number of patients in each group showing complete disappearance of the skin lesion over 3 months of intervention will be the primary outcome, measured at baseline, every month, up to 3 months. Pruritus intensity measuring 0-10 numeric rating scale and Skindex-29 questionnaire will be the secondary outcomes - measured at baseline, every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |