Repertorial approach of treating tinea corporis using individualised homoeopathic medicines: Double-blind, randomized, placebo-controlled efficacy trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- 5-D pruritus scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients suffering from tinea corporis (B35.4) for 3 months or more, diagnosis confirmed through KOH mount test
- •Age between 18 and 65 years
- •Patients of either sex
- •Literate patients; ability to read English and/or Bengali
- •Providing written informed consent
- •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
- •Similar looking skin conditions; e.g., seborrheic dermatitis, pityriasis rosea and psoriasis
- •Vulnerable population – Unconscious, differently abled, terminally or critically ill patients, mentally incompetent people
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
- •Pregnant and puerperal women, lactating mothers
- •Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months.
Outcomes
Primary Outcomes
5-D pruritus scale
Time Frame: Baseline, every month, up to 3 months
Secondary Outcomes
- 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)