A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of a Unani Formulation ̶ Qurá¹£-i Sa‘fa (T) in the management of QÅ«bÄ (Tinea Corporis and Tinea Cruris).
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
- 1. Total Signs & Symptoms Score (TSSS) (Clinical Cure)
研究概览
简要总结
According to observations worldwide, dermatophytosis is the most common of the superficial fungal infections. It is more common in tropical region and may present in epidemic proportions in areas with high rates of humidity. Skin mycoses are currently one of the most common types of infections, affecting more than 20–25% of the global population due to a significant increase in the incidence of superficial mycotic infections over the past several decades. In India, it is more prevalent in Southern states as the climate of these areas are more hot and humid which is favorable for the dermatophytes.There are many unani formulations which are mentioned and being used from several decades. Although those formulations were used by many ancient Unani physicians and still are being used but some of them are not yet scientifically evaluated on modern parameters. Keeping this in view, the present study was designed to evaluate the safety and efficacy of the polyherbal formulation in case of QÅ«bÄ. Which is taken from Al-Qarabadin.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of QÅ«bÄ (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
- •Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic hyphae.
排除标准
- •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.
- •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 Qurá¹£-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.
结局指标
主要结局
1. Total Signs & Symptoms Score (TSSS) (Clinical Cure)
时间窗: 42 Days
2. Conversion to Negative Mycology (Mycological Cure)
时间窗: 42 Days
3. DLQI (Dermatology Life Quality Index)
时间窗: 42 Days
次要结局
- Systemic Safety assessment(42 Days)
研究者
Dr Sultan Ul Haque
National Research Institute Of Unani Medicine For Skin Disorders