A Randomized, Multi-center, Prospective, Comparative Clinical Study to evaluate efficacy and safety of AP/VJT/SBO Ayurvedic Hair Oil in mild to moderate Hair loss in females
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 1.Comparative assessment of hair fall by running finger test
研究概览
简要总结
It is a randomized, multi-center,prospective, comparative, clinical study to evaluate efficacy and safety of AP/VJT/SBO Ayurvedic Hair Oil inmild to moderate hair loss in females. The study will be conducted in three centersin India. Subjects will be asked to apply approximately 10 ml of hair oil for minimum3 times a week. The primary objectiveof the study will be to assess hair fall by running finger test and hairbreakage by comb test. The secondaryobjectives of the study will be to assess hair fall by Hair Pull test, hairgrowth, effect on dandruff, effect on quality of hair, global assessment ofoverall change by physician and subject and assessment of safety and adverseevents on screening visit, baseline visit, day 15, day 30, day 45 and day 60
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subjects suffering from mild to moderate hair loss (40-140 Hair by Comb test and Finger Test).
- •2.Subjects who are infrequent hair oil users 3.Subjects who are willing to give informed consent and ready to comply with the protocol 4.Subjects who are ready to provide regular follow ups till the completion of the study.
排除标准
- •1.Subjects with severe Hair fall due to any clinically significant disorder/s like anemia, thyroid disorders etc.
- •2.Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation 3.Subjects with recent disease history like, malaria, typhoid, jaundice and scalp diseases and subjects who in the opinion of the investigator are not eligible for enrollment in the clinical study 4.Subjects who have regularly used anti-hair fall treatment with hair oils over the last 6 months.
- •5.Subjects who have previously undergone hair transplantation procedures 6.Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
- •7.Subjects on immunosuppressive drugs 8.Known cases of Hypersensitivity to hair oil contents 9.Subjects who have participated in any other clinical study since last 3 months 10.Subjects who are reported pregnant/planning a pregnancy or lactating.
- •11.Menopausal Women.
结局指标
主要结局
1.Comparative assessment of hair fall by running finger test
时间窗: Screening visit, Baseline visit, Day 15, Day 30, Day 45 and Day 60
2.Comparative assessment of hair breakage by comb test
时间窗: Screening visit, Baseline visit, Day 15, Day 30, Day 45 and Day 60
次要结局
- 1.Comparative assessment of hair fall by Hair Pull test(2.Comparative assessment of hair growth)