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Clinical study of Unani Formulation in Tinea Corporis

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Topical Unani Formulation In The Management Of Qub ? (Tinea Corporis) - NA

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068679
Enrollment
60
Registered
2024-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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(homogenous powder as paste in water): Composition:Tukhm-i-panwad (Foetid cassia)Amla (Indian gooseberry) Laakh (Kerria lac insect) Zeera (cuminum cyminum) Dos

Sponsors

National Research Institute Of Unani Medicine For Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Participants of any gender in age group of 18-60 years 2 Participants of Qub ?(Tinea Corporis) 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 3 Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic hyphae Participants who are willing to participate and comply with the protocol and sign to IEC approved ICF.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Total Signs & Symptoms Score (TSSS) (Clinical Cure) 2. Conversion to Negative Mycology (Mycological Cure) Timepoint: TSSS At baseline 2nd, 4th and on 6th weeks. Mycological Cure at baseline and on 6th week.

Secondary

MeasureTime frame
DLQI (Dermatology Life Quality Index)Timepoint: At baseline 2nd, 4th and on 6th weeks.

Countries

India

Contacts

Public ContactDr Madeeha Bano

National Research Institute Of Unani Medicine For Skin Disorders

drnasar.nriumsd@gmail.com8328446962

Outcome results

None listed

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