A Single-Arm, Open-Label, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Amrutveni DandroQit shampoo in the Management of Mild to Moderate Dandruff
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This open-label, single-arm, interventional clinical study evaluates the therapeutic efficacy and safety of Amrutveni DandroQit shampoo 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
- 10.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged 10 to 55 years.
- •Clinical diagnosis of mild to moderate dandruff, defined by a Flake Severity Score (FSS) of 1–
- •Willingness to abstain from using any other hair care or anti-dandruff products throughout the study duration.
- •Voluntary participation with written informed consent.
排除标准
- •Participants with other known scalp disorders (e.g., psoriasis, seborrheic dermatitis, tinea capitis).
- •Individuals with known hypersensitivity or allergy to any of the shampoo components.
- •Use of systemic corticosteroids, antifungals, or antibiotics in the past 4 weeks.
- •Participation in another clinical study in the last 30 days.
- •Pregnant or lactating women.
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation