Therapeutic Evaluation of a Topical Unani Formulation in Pityriasis Versicolor (Bahaq) and Its Comparative Study with Luliconazole 1 Percent Ointment: A Randomized, Parallel Group, Open-Label, Standard-Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mycological cure rate of KOH examination of skin scrap (Direct Microscopy) at the end of 45 days.
研究概览
简要总结
Bahaq (Pityriasis versicolor) is a superficial fungal infection caused by Malassezia furfur, commonly affecting young adults. Though effective treatments exist in conventional medicine, challenges persist due to frequent recurrences, pigmentary changes, and potential side effects of oral antifungals, including hepatotoxicity and rare cardiac complications. The condition often leads to cosmetic concerns and emotional distress. Unani medicine has long used herbomineral remedies for Bahaq, but lacks scientific validation. This study aims to evaluate the safety and efficacy of a topical Unani formulation in managing Bahaq Aswad using modern clinical tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group above 16 to 45 years Sex: Both males & females Patient with any of the sign and symptoms of Bahaq (Pityriasis Versicolor) Hyper pigmented macule, Erythema, Pruritus on the lesion, Scaling / Desquamation.
- •Presence of Malassezia furfur in the scrapings of the lesion.
排除标准
- •Patient with serious co-morbid medical condition and other fungal infection Participant who had received any systemic or topical antimycotic therapy within month of start of study Significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction Known cases of Immunocompromised states (HIV, AIDS, etc.) Malignancies Patient not willing to attend treatment schedule regularly Person, Individual with any active Psychiatric illness KoH mount test negative.
结局指标
主要结局
Mycological cure rate of KOH examination of skin scrap (Direct Microscopy) at the end of 45 days.
时间窗: 45 Days
次要结局
- Improvement in subjective parameters (Hypopigmentation, Scaling & Itching) of skin lesions evaluated by(an arbitrary grading scale, Total Sign & Symptom Score (TSSS) assessed on four point scale (0 absent, 1 mild, 2 moderate, 3 severe))