A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to compare the Efficacy of Qurs-e-Asfar(O) and Marham-e-Dad (L) with Itraconazole(O) and Terbinafine (L) in the Management of Quba (Dermatophytosis) along with Gene expression and Biomarkers Analysis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 59
- 试验地点
- 1
研究概览
简要总结
Dermatophytosis is a common fungal skin infection, particularly prevalent in tropical regions like India, often causing recurrent lesions and resistance to standard antifungal drugs. The present single-center, randomized, open-label, active-controlled, parallel-group clinical study aims to evaluate the efficacy and safety of Unani formulations Qurs-e-Asfar (oral) and Marham-e-Dad (topical)—in participants of Quba also called as Tinea corporis (body) and Tinea cruris (groin), in comparison to standard antifungal drugs. The study will also assess gene expression changes (CXCL-8, CXCL-1, and TSG-6) using RT-PCR and measure serum biomarker levels (IL-6, IL-17, IL-23, and TNF-alfa) by ELISA before and after treatment, to understand their association with therapeutic outcomes. This research seeks to provide scientific validation for Unani medicines in managing Quba and explore genetic and protein biomarkers contributing to disease pathogenesis and treatment response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of Quba Tinea Corporis (body) & Tinea Cruris (groin) having Circumscribed lesions having any of the following signs and Symptoms: Presence of pruritus and burning, Presence of scales, Presence of central clearing, Erythematous papules.
- •Participants with positive mycology (KOH positive).
- •Willingness to participate in the study and follow the schedule.
排除标准
- •Participants below 18 years or above 60 years of age, pregnant or lactating women, and those having other forms of tinea infection such as Tinea capitis (scalp), Tinea pedis (foot), Tinea manuum (hands), Tinea unguium (nails), Tinea barbae (beard), or Tinea faciei (face) will be excluded from the study.
- •Patients suffering from psoriasis, eczema, diabetes mellitus, pulmonary, cardiovascular, hepatic, or renal dysfunction, or any immunocompromised condition such as HIV/AIDS will also be excluded.
- •Participants unwilling to attend the treatment schedule regularly, those with a history of hypersensitivity to Itraconazole or Terbinafine, and those who have used systemic antifungal or corticosteroid therapy in the previous two weeks will not be included in the study.
研究者
Syeda Hajra Fatima
National Research Institute of Unani medicine for Skin Disorders