CTRI/2020/01/023074暂停不适用
A Randomized, Double-blind, Placebo-controlled, Parallel group, Observational ClinicalTrial to evaluate the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptidecapsule 250 mg) Versus Maltodextrin Oral Capsule on hair and nail parameters.
Maxcure Nutravedics Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年3月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1. Change in hair and nail parameters
研究概览
简要总结
The study will be conducted after obtaining written informedconsent voluntarily from the subjects. The subjects will undergo screening procedures.
General examination, vital signs will be recorded for eachvisit. The aim of this study is to evaluate and compare the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptide capsule 250 mg) versus Maltodextrin Oral Capsule on hair and nail parameters in a randomized, double-blind, Placebo-controlled, Parallel group, Observational clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •All subjects willing to fill and sign ICFs [Informed Consent Forms]
- •Only females having age ≥ 25 to ≤ 65 years.
- •Females having clinical signs of stressed or damaged hairs.
- •Females with an agreement, not to use other possible cosmetic treatments which could interfere with the study.
- •Subject able to follow study procedures.
- •In generally good health.
- •Female, using birth control
- •Subjects ready to follow-up for entire duration of the study.
排除标准
- •Subjects unwilling to sign on ICF
- •Any dermatological condition of the scalp other than hair loss and /or dandruff.
- •Any prior hair growth procedures (e.g., hair transplant or laser)
- •History of alcohol or drug addiction
- •History of skin allergy
- •Any active skin infection in the scalp area or scarring in the target area.
- •Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year.
- •Subject had participated in any investigational study within the 30 days prior to trial.
- •A history or the presence of any serious and/or chronic medical condition(s) including psychiatric illnesses] which, in the opinion of the investigator, may cause harm to the individual and/or compromise/confound the study results.
- •Subjects unwilling or unable to comply with the study procedures.
结局指标
主要结局
1. Change in hair and nail parameters
时间窗: 1. Visit 3,4 and 5 | 2. Visit 5
2. Physician’s and subjects’ Global Assessment
时间窗: 1. Visit 3,4 and 5 | 2. Visit 5
次要结局
- 1. Number of participants reporting adverse events(2. Mean change in the vital parameters from baseline to each post randomization visit)
研究者
研究点 (1)
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