CTRI/2026/04/108451尚未招募不适用
AN OPEN-LABEL, SINGLE-ARM, SINGLE-CENTRE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TATKAL CAPSULES IN TREATING ERECTILE DYSFUNCTION
Renovision Exports Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Purpose of the StudyThe purpose of this study is to evaluate the safety and effectiveness of the investigational Ayurvedic proprietary formulation in adult male participants with erectile dysfunction. The study aims to assess changes in erectile function–related parameters and overall sexual health during the treatment period, while monitoring tolerability, compliance, and adverse events, in order to generate clinical evidence under controlled conditions.
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects aged twenty five to sixty years.
- •Subjects who are willing and able to provide written informed consent before starting any study related procedures.
- •Subjects with a confirmed diagnosis of erectile dysfunction for more than six months and less than five years.
- •Subjects having a baseline International Index of Erectile Function erectile function score between eleven and twenty five, indicating mild to moderate erectile dysfunction.
- •Subjects who are in a stable relationship for at least three months before screening and have a history of at least two sexual attempts per month for at least one month prior to enrollment.
- •Subjects who are willing to follow all study procedures, attend scheduled visits, take the study medication as instructed, and complete the study diary.
- •Subjects who are generally healthy, with no major active infections or clinically significant medical conditions, as assessed by the investigator.
排除标准
- •Subjects with known hypogonadism or structural abnormalities of the penis, including severe penile fibrosis.
- •Subjects with a history of significant heart related diseases such as congestive heart failure, life threatening irregular heart rhythm, or ischemic heart disease.
- •Subjects with an ongoing history of alcohol abuse or drug abuse.
- •Subjects with neuromuscular disorders that affect sexual function.
- •Subjects diagnosed with secondary hypertension.
- •Subjects having severe complications of diabetes such as heart disease, kidney disease, or foot ulcer.
- •Subjects who have participated in another clinical trial within the last thirty days prior to enrollment.
- •Subjects with known allergy or hypersensitivity to any of the ingredients of Tatkal Capsules.
- •Subjects who are unwilling or unable to provide written informed consent.
研究者
Dr B N Satish
Upadhyaya Ayurveda Bhandara
研究点 (1)
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