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 QÅ«bÄ (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
- 1. Total Signs & Symptoms Score (TSSS)
研究概览
简要总结
Tinea /ringworm infection is caused by a distinct class of fungi, the dermatophytes. They thrive in the keratin layer of the epidermis, nails and hair. Trichophyton, Microsporum, and Epidermophyton, and affecting 20–25% of the world population with varying geographic distribution. There are several unani formulations are being used in the management of this disease but most of them are lack of evidence based clinical trials, Hence, the present study is entitled to evaluate the safety and efficacy of Unani Formulation in the management of QÅ«bÄ.
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 Participants of any gender in age group of 18-60 years 2 Participants of QÅ«bÄ(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.
排除标准
- •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.
结局指标
主要结局
1. Total Signs & Symptoms Score (TSSS)
时间窗: TSSS At baseline 2nd, 4th and on 6th weeks. | Mycological Cure at baseline and on 6th week.
(Clinical Cure)
时间窗: TSSS At baseline 2nd, 4th and on 6th weeks. | Mycological Cure at baseline and on 6th week.
2. Conversion to Negative Mycology
时间窗: TSSS At baseline 2nd, 4th and on 6th weeks. | Mycological Cure at baseline and on 6th week.
(Mycological Cure)
时间窗: TSSS At baseline 2nd, 4th and on 6th weeks. | Mycological Cure at baseline and on 6th week.
次要结局
- DLQI (Dermatology Life Quality Index)(At baseline 2nd, 4th and on 6th weeks.)
研究者
Dr Madeeha Bano
National Research Institute Of Unani Medicine For Skin Disorders