CTRI/2022/03/041069已完成不适用
A double-blind, randomised, placebo controlled, parallel group study to evaluate the efficacy and safety of Libidolyn® in improving erectile function and maintain normal sexual health.
Herbalyn Lifesciences Inc1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 at 90 day Endpoint.
研究概览
简要总结
This is a study to understand the efficacy and safety of poly herbal (Libidolyn Capsules) for erectile function and maintain normal sexual health in subjects in comparison with placebo. The duration ofthe study is 97 days (including screening).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects aged 25 to 50 years in general good health having a stable female partner for past three months.
- •At least a 3-month history of erectile dysfunction (ED).
- •Are able to read, understand and provide signed informed consent.
- •Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 12 and less than 18 (having Moderate severity of Erectile Dysfunction) at Randomization visit.
- •The subjects are anticipated to have the same female sexual partner during the study, who is willing to be associated with the male subjects’ attempts and complete study measures during the study.
- •Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the double-blind treatment period and for 96 hours after the end of the study.
排除标准
- •Have an IIEF-EF domain score of greater than or equal to 26 at screening.
- •Present with ED caused by other primary disorders such as hypertension, diabetes mellitus, obesity or other untreated/inadequately treated endocrine disease including the psychogenic ED.
- •History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator d.
- •Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator e.
- •Currently receiving treatment with nitrates, cancer chemotherapy, vasodilators, drugs for neurological conditions or antiandrogens f.
- •Subjects with mental disorders including performance anxiety g.
- •History of tobacco, drug and alcohol abuse including current smoker h.
- •Subject who has participated in a clinical study within the last 30 days prior to entering this study.
- •Subject with hypersensitivity to any of the study products.
结局指标
主要结局
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 at 90 day Endpoint.
时间窗: Baseline to Day 90
次要结局
- • Change From Baseline to 90 days Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score, Intercourse Satisfaction (IIEF-IS) Domain Score, Overall Satisfaction (IIEF-OS) Domain Score(• Change From Baseline to 90 day Endpoint serum testosterone & serum prolactin.)
研究者
研究点 (1)
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