A Prospective, Placebo control, Comparative, Clinical Study to Evaluate the Efficacy and Safety of Zandu Hair Growth Ayurvedic Capsule in Promoting Hair Growth, Reducing Hair Fall, and Improving Hair Quality in Adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- scalp areas, before and after 90 days of treatment
研究概览
简要总结
This Phase III, multicentric, randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of Zandu Hair Growth Ayurvedic Capsule in promoting hair growth, reducing hair fall, and improving hair quality over 90±2 days. Sponsored by Emami Group and managed by Manentia Research Pvt. Ltd., the study enrolls 60 adults (1:1 randomization) with hair thinning or loss for at least three months. Subjects receive either the test product (one capsule twice daily) or a placebo. Primary endpoints include hair growth assessment via hair count and length, while secondary endpoints measure reduction in hair fall, hair texture improvements, and increased hair density. Safety is monitored through blood tests and adverse event tracking. Study visits occur at screening, randomization, follow-ups (Days 30, 60), and end-of-study (Day 90)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged between 20 to 55 years and female subjects aged between 18 to 45 years.
- •2.Individuals experiencing hair fall, hair thinning, or complaints of poor hair texture for at least 3 months.
- •3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •1.Participants with a known allergy or hypersensitivity to any ingredient in the Zandu Hair Growth Ayurvedic Capsule or similar products.
- •2.Individuals with significant dermatological conditions affecting the scalp, such as psoriasis, eczema, seborrheic dermatitis, or active scalp infections.
- •3.Participants who have undergone hair treatments such as hair transplants, chemical treatments (dyes, perms, straightening), or the use of hair growth products (e.g., minoxidil, finasteride) within the last 6 months.
- •4.Pregnant or breastfeeding women.
- •5.Participants currently taking or having taken hormonal therapies (e.g., corticosteroids, hormonal birth control, testosterone supplements) within the past 3 months.
- •6.Participants who have undergone major surgery within the last 3 months.
- •7.Individuals who have received chemotherapy or radiation therapy within the past 12 months.
- •8.Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator.
- •9.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •10.Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •11.Suspected inability or unwillingness to comply with the study procedures.
- •12.Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
- •13.Pregnant woman or lactating mother.
结局指标
主要结局
scalp areas, before and after 90 days of treatment
时间窗: 90 days
Increase in Hair Growth: Measured by hair count and hair length from standardized
时间窗: 90 days
次要结局
- Reduction in Hair Fall: Assessed through participant-reported hair shedding (e.g., hair(strands lost during combing or washing), and visual or quantitative assessments at)
研究者
Dr Sandeep Sharma
Jindal Super Specility Hospital