Homeopathic medicines for fungal infection

Phase 2/3

Recruiting

Brief Summary: The prevalence ofsuperficial mycotic infection worldwide is 20-25% of which dermatophytes arethe most common agents. Homeopathypeer-reviewed research in tinea infection has remained seriously compromised. A double-blind, randomized, placebo-controlledtrial on 128 participants is attempted at D. N. De Homoeopathic Medical Collegeand Hospital to identify the differences between individualized homeopathicmedicines and identical-looking placebos in treatment of tinea corporisafter 3 months of intervention. Participants will be randomized into eitherverum (n=64) or placebos (n=64) in the mutual context of concomitant care,e.g., application of olive/coconut oil, maintaining local hygiene, keeping thearea dry, etc. Primary outcome measure is 5-D pruritus scale and secondaryoutcome measures are Skindex-29 questionnaire and dermatological life qualityindex (DLQI) questionnaire; all to be measured at baseline, and every month, upto 3 months. Comparative analysis will be carried out to detect groupdifferences. Results will be published in scientific journals.

Recruitment & Eligibility

Inclusion Criteria

Patients suffering from tinea corporis (B35.4) for 3 months or more, diagnosis confirmed through KOH mount test 2.
Age between 18 and 65 years 3.
Patients of either sex 4.
Literate patients; ability to read English and/or Bengali 5.
Providing written informed consent 6.
Patient using topical agents for tinea lesions will be included after a washout period of two weeks.

Exclusion Criteria

Cases with complication like lichenification and eczematisation 2.
Similar looking skin conditions; e.g., seborrheic dermatitis, pityriasis rosea and psoriasis 3.
Vulnerable population â€“ Unconscious, differently abled, terminally or critically ill patients, mentally incompetent people 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 puerperal women, lactating mothers 6.
Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence 7.
Self-reported immune-compromised state 8.
Already undergoing homoeopathic treatment for chronic disease within last 6 months.

Primary Outcome Measures

Name	Time	Method
5-D pruritus scale	Baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
Skindex-29 questionnaire total and subscale scores	Baseline, every month, up to 3 months
Dermatological life quality index (DLQI) total and subscale scores	Baseline, every month, up to 3 months

Locations (1): D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal
🇮🇳
Kolkata, WEST BENGAL, India
D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal
🇮🇳Kolkata, WEST BENGAL, India
Dr Shruti Maharaj
Principal investigator
8777270458
shrutimaharaj7@gmail.com