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 Quba (Tinea corporis).
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3. DLQI (Dermatology Life Quality Index
研究概览
简要总结
Dermatophytes are fungi responsible for tinea (ringworm) infections, affecting the hair, nails, and skin’s keratin layer. These infections are prevalent globally, particularly in tropical and subtropical regions, and are caused by fungi from three genera: Trichophyton, Microsporum, and Epidermophyton. Dermatophyte infections often result in annular skin lesions and can cause significant social, psychological, and economic issues in developing countries.
The treatment of dermatophyte infections can be challenging, especially with rising treatment failure rates. Common antifungal medications like chlorhexidine, itraconazole, and fluconazole can have severe side effects, particularly in pregnant women and children.
Traditional Unani medicine offers alternative treatments using formulations that contain ingredients like sulfur, copper sulfate, and borax, known for their anti-inflammatory, antiseptic, and blood-purifying properties. A clinical trial is underway to assess the safety and effectiveness of a topical Unani formulation for managing tinea corporis, as many of these treatments have yet to be scientifically evaluated.
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
- •1 Individuals with circumscribed lesions on the body and limbs, presenting with any of the following signs and symptoms: Pruritus and burning sensation Presence of scales Central clearing of the lesion Erythematous papules 2 Additionally, participants must have a positive KOH (10%) smear microscopy from a skin scraping of the active lesion, confirming the presence of dermatophytic hyphae.
排除标准
- •1 Age below 18 years and above 60 years.
- •2 Patients with other form of tinea infection like,tinea capitis, tinea pedis, tinea manuum, tinea unguium, tinea barbae 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 unani formulation.
- •9 Pregnant or lactating women, and women desiring pregnancy.
- •10 Participants not willing to give consent and to attend treatment schedule regularly.
结局指标
主要结局
3. DLQI (Dermatology Life Quality Index
时间窗: TSSS at Baseline 2nd, 4th and 6th wees. | Mycological cure at baseline and on 6th week
1. Total Signs & Symptoms Score (TSSS)
时间窗: TSSS at Baseline 2nd, 4th and 6th wees. | Mycological cure at baseline and on 6th week
(Clinical Cure)
时间窗: TSSS at Baseline 2nd, 4th and 6th wees. | Mycological cure at baseline and on 6th week
2. Conversion to Negative Mycology
时间窗: TSSS at Baseline 2nd, 4th and 6th wees. | Mycological cure at baseline and on 6th week
(Mycological Cure)
时间窗: TSSS at Baseline 2nd, 4th and 6th wees. | Mycological cure at baseline and on 6th week
次要结局
- DLQI (Dermatology Life Quality Index)(Systemic Safety assessment)
研究者
DR ANISUR REHMAN SHAIKH
National Research Institute Of Unani Medicine For Skin Disorders
