Homeopathic medicines for ringworm

Phase 2

Recruiting

Conditions: Tinea corporis,

Registration Number: CTRI/2019/11/021999

Lead Sponsor: National Institute of Homoeopathy

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 62

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Skindex-29 questionnaire	Baseline, every month, up to 3 months
Intensity of pruritus measured by 0-10 numeric rating scales	Baseline, every month, up to 3 months

Trial Locations

Locations (1): National Institute of Homoeopathy
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
Bakibillah Laskar
Principal investigator
9064304443
blaskar113@gmail.com