CTRI/2020/11/028782已完成不适用
An open label Single center Prospective Study to evaluate efficacy and safety of two Ayurvedic Combination(s) in treatment of co-existing Erectile Dysfunction and Premature Ejaculation
DrSankalp Jain1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月11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
- 100
- 试验地点
- 1
- 主要终点
- The safety and tolerability of the investigational product will be
研究概览
简要总结
It is a Investigator initiate clinical study which involves the collection of clinical data to evaluate the safety and effectiveness of Ayurvedic Combination(s) in treatment of co-existing Erectile Dysfunction & Premature Ejaculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects between 18 to 64 years of age.
- •Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study.
- •Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 25; as specified in Urology 1999, 54: 346-351).
- •Subjects meeting with diagnostic criteria for premature ejaculation (PE score greater than or equal to 11) as specified in article published in European Urology 2007, 52: 565-
- •Subject and his partner agreeing to attempt sexual intercourse 2 times/ week.
- •Subject willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Previous events or other conditions associated with premature ejaculation/erectile dysfunction including but not limited to spinal trauma or pelvic surgery.
- •Subjects with genital anatomical deformities including but not limited to penile deformities.
- •Subjects with erectile dysfunction or premature ejaculation due medication withdrawal.
- •Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
- •Subjects with major psychiatric illness or previous suicidal attempts.
- •Subjects with history of epilepsy
- •Subjects with history of stroke, myocardial infraction, heart failure, unstable angina, life-threatening arrhythmia and hypotension with in past 6 months.
- •Subjects for whom sexual activity is inadvisable because of their underlying disease status.
- •Subject is a known case of autonomic neuropathy, retinitis pigmentosa, bleeding disorders, sickle cell anemia and active peptic ulcer disease.
- •Subjects with significant and uncontrolled hematological/metabolic/ endocrinologial/respiratory/cardiovascular/neurological/psychiatric /liver/kidney diseases.
- •Subjects with resting hypotension (BP 90/50) or hypertension ( BP 170/110) Proprietary and confidential informat.
结局指标
主要结局
The safety and tolerability of the investigational product will be
时间窗: Day 1, Day 35
Proprietary and confidential information Page 8 of 29
时间窗: Day 1, Day 35
assessed by the Clinical AEs, including laboratory abnormalities
时间窗: Day 1, Day 35
Assessment Intervals Day 1 Day 35
时间窗: Day 1, Day 35
次要结局
- Improvement Sperm concentration per milliliter of seminal fluid(Improvement Proportion of Sperm motility)
研究者
研究点 (1)
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