Efficacy of Joshanda Mussaffi orally with local application of Tila versus Clotrimazole 1% lotion in Tinea Incognito–A Single Blind Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
This randomized, single-blind controlled clinical trial aims to evaluate the efficacy of Joshanda Mussaffi given orally along with the local application of Tila (Unani formulation) in comparison with topical Clotrimazole 1% lotion for the management of Tinea Incognito. Tinea Incognito is a dermatophytic infection modified by prior inappropriate corticosteroid use, often presenting with atypical features and delayed diagnosis.
A total of eligible patients fulfilling the inclusion and exclusion criteria will be randomly allocated into two groups. Group A will receive Joshanda Mussaffi orally with local application of Tila, while Group B will receive standard therapy with topical Clotrimazole 1% lotion. Sample size no 42.The treatment duration, follow-up schedule, and outcome assessment will be uniform for both groups.
The primary outcome will be the reduction in clinical severity based on signs and symptoms scoring. Secondary outcomes include improvement in pruritus, lesion size reduction, and mycological clearance confirmed by KOH microscopy. Safety assessment and adverse event monitoring will also be conducted throughout the study.
The study aims to scientifically validate the effectiveness and safety of traditional Unani treatment compared to standard antifungal therapy for Tinea Incognito.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)(—)
- 性别
- All
入选标准
- •1 all gender 2 age between 18 to 65 3 known case of tinea incognito with chronicity equal or more then 6 month 4 clinically diagnose and mycologically confirm cases with treatment history of steroid 5 subject with diabetes mellitus with hba1c equal or more then 8 percent 6 subject who have agree to sign innform consent form.
排除标准
- •1 Subjects with other skin diseases like psoriasis and eczema etc.
- •2 Subjects with history of hypertension, hypothyroidism, Tuberculosis, malignancy, on immunosuppressants, contraceptives and uncontrolled diabetes mellitus, dyslipidemia, hepato renal dysfunctions.
- •3 Subjects with history of treatment with antifungals, topical or systemic corticosteroids therapy in the past 4 weeks.
- •4 Pregnant and lactating women.
研究者
Dr khan shahina bano mohd vakeel
national institute of unani medicine
