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A Clinical Study on Tinea Corporis And Tinea Cruris

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Unani Formulation (Topical) Compared With Terbinafine (Topical) In The Management Of Quba (Tinea Corporis And Tinea Cruris) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096590
Enrollment
60
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Topical Unani Formulation: Form: Habb(Pill) to be used in the form of Tila(liniment), Route of Administration: Topical Application, Quantity: Quantity sufficient based on the extent of

Sponsors

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of any gender in age group of 18-60 years 2. Participants of Quba (Tinea Corporis and Tinea Cruris) having circumscribed lesions with any of the following signs and symptoms on body, limbs and groin: a. Presence of pruritus and burning b. Presence of scales c. Presence of central clearing d. Erythematous papules 3. Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic Hyphae

Exclusion criteria

Exclusion criteria: 1. Age below 18 years and above 60 years 2. Patients with other form of tinea infection like tinea capitis (head), tinea pedis (foot), tinea mannum (hands), tinea unguium (nails), tinea barbae (beard), tinea faciei (face), etc. 3. Patients with other concomitant diseases like psoriasis & eczema 4. Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks 5. Participants not willing to give consent and to attend treatment schedule regularly 6. Patients with known active pulmonary/cardiovascular/ liver/ renal or neurological diseases 7. Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies 8. Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy 9. History of hypersensitivity to either Terbinafine or any test drug 10. Pregnant or lactating women, and women desiring pregnancy

Design outcomes

Primary

MeasureTime frame
1. Change in Total Signs & Symptoms Score (TSSS). 2. Change in mycology finding (KOH mount).Timepoint: TSSS at baseline, 2nd, 4th and 6th week KOH mount at baseline and 42nd day

Secondary

MeasureTime frame
1.DLQI (Dermatology Life Quality Index) 2.Systemic Safety AssessmentTimepoint: DLQI at baseline, 2nd, 4th and 6th week Systemic Safety Assessment at baseline and 6th week

Countries

India

Contacts

Public ContactDr Farhana Farheen Aqueel Ahmed

National Research Institute of Unani Medicine for Skin Disorders, Hyderabad

aarzu763@gmail.com9032519286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026