Evaluating efficacy and safety of Unani Formulation in Tinea Corporis and Tinea Cruris

Phase 2

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

Registration Number: CTRI/2023/11/059444

Lead Sponsor: ational Research Institute Of Unani Medicine For Skin Disorders

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Participants of Qub ? (Tinea corporis and Tinea cruris) having circumscribed lesions with any of the following signs and symptoms on body and limbs:

A)Presence of pruritus and burning

B)Presence of scales

C)Presence of central clearing

D)Erythematous papules

2. Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic hyphae.

Exclusion Criteria

The following patients will be excluded:

1) Age below 18 years and above 50 years

2) Patients with other form of tinea infection like tinea pedis, tinea manuum, tinea unguium, tinea faciei, etc.

3) Patient 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) Patients with known active pulmonary/ cardiovascular/ liver/ renal or neurological diseases

6) Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies

7) Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy

8) History of hypersensitivity to either clotrimazole or Qur?-i Sa‘fa

9) Pregnant or lactating women, and women desiring pregnancy

10) Participants not willing to give consent and to attend treatment schedule regularly.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Total Signs & Symptoms Score (TSSS) (Clinical Cure) <br/ ><br>2. Conversion to Negative Mycology (Mycological Cure) <br/ ><br>3. DLQI (Dermatology Life Quality Index)Timepoint: 42 Days

Secondary Outcome Measures