An Open-Label, Single-Arm, Interventional Clinical Test to Evaluate the Efficacy of Amrutveni LiceQit oil in Reducing Head Lice and Nit Count
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mean percentage reduction in live lice and nit count from baseline (Day 0) to Day 28, determined by standardized lice detection combing and count comparison
研究概览
简要总结
This open-label, single-arm interventional clinical study aims to evaluate the efficacy and safety of Amrutveni LiceQit Oil in reducing head lice and nit infestation. A total of participants with clinically confirmed pediculosis will undergo baseline assessment followed by treatment and periodic evaluations on Days 1–7, 14, 21, and 28. Efficacy will be measured by percentage reduction in live lice and nit counts, improvement in itching, scalp comfort, and hair quality. Safety will be assessed through monitoring of erythema, irritation, and other local adverse reactions. The study seeks to establish Amrutveni LiceQit Oil as a safe herbal anti-lice formulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Individuals aged between 18 and 60 years Presence of head Lice infestation.
排除标准
- •Known hypersensitivity or allergy to any ingredients present in the Amrutveni LiceQit Oil.
- •Presence of underlying dermatological scalp disorders such as psoriasis, seborrheic dermatitis, or eczema.
- •Use of other anti-lice treatments or pediculicides within the preceding 7 days.
- •Participation in any other clinical test within the past 30 days.
- •Pregnant or lactating women, due to unknown effects on maternal or neonatal health.
结局指标
主要结局
Mean percentage reduction in live lice and nit count from baseline (Day 0) to Day 28, determined by standardized lice detection combing and count comparison
时间窗: Day 0 (baseline), Day 1–7, Day 14, Day 21, and Day 28
次要结局
- 1. Change in Pediculosis Severity Score (PSS) from Day 0 to Day 28.(2. Change in itching intensity (VAS, 0–10).)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation