Skip to main content
Clinical Trials/CTRI/2022/04/042077
CTRI/2022/04/042077RecruitingPhase 2/3

Repertorial approach of treating tinea corporis using individualised homoeopathic medicines: Double-blind, randomized, placebo-controlled efficacy trial

D N De Homoeopathic Medical College Hospital1 site in 1 country128 target enrollmentStarted: April 25, 2022Last updated:

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)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials