A Single-Arm, Open-Label, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Amrutveni The D Oil DandroQit in the Management of Mild to Moderate Dandruff
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sahyadri Bio Labs Pvt. Ltd.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Dandruff Severity Index (DSI; 0–9, clinician-rated) from baseline (Day 0) to end of treatment (Day 21).
概览
简要总结
This open-label, single-arm, interventional clinical study evaluates the therapeutic efficacy and safety of Amrutveni DandroQit Oil in the management of mild to moderate dandruff. A total of participants meeting inclusion criteria will apply the investigational oil for 21 days. Efficacy will be assessed using clinician- and patient-reported outcomes, including Dandruff Severity Index (DSI), Adherent Scalp Flaking Score (ASFS), pruritus (VAS), and Investigator Global Assessment (IGA). Cosmetic and user satisfaction outcomes will also be recorded. Safety will be monitored through local irritation scores and adverse event reporting. The study aims to determine clinical improvement and scalp tolerability following treatment.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female participants aged 18 to 55 years.
- •Clinically diagnosed cases of mild to moderate dandruff, confirmed by Flake Severity Score.
- •Willingness to refrain from using other topical or oral anti-dandruff agents or hair treatments during the study.
- •Written informed consent provided after being briefed about the study.
排除标准
- •Diagnosed cases of other scalp dermatoses (e.g., psoriasis, tinea capitis, seborrheic dermatitis).
- •History of hypersensitivity or allergic reactions to any ingredients of the study product.
- •Use of systemic corticosteroids, antibiotics, or antifungals within the past 4 weeks.
- •Participation in another clinical trial in the past 30 days.
- •Pregnant or lactating women.
结局指标
主要结局
Change in Dandruff Severity Index (DSI; 0–9, clinician-rated) from baseline (Day 0) to end of treatment (Day 21).
时间窗: Day 0 (Baseline), Days 1–7 (daily symptom/safety tracking), Day 7, Day 14, and Day 21 (end of treatment).
次要结局
- Change in Adherent Scalp Flaking Score (ASFS; 0–100).(Change in Pruritus intensity (VAS 0–10 cm).)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation