CTRI/2009/091/000099招募中2 期
A Triple blind, placebo controlled, randomized study to evaluate the Safety and Efficacy of VigRX Plus capsules as a dietary supplement to improve erectile function and maintain Male Sexual Health
DM Contact Management Ltd0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male subjects aged between 25-50 years
- •2.Subject having a monogamous, heterosexual relationship
- •3.Male subjects with IIEF-A score 11 to 23 & IIEF-B score 21 to 35 at screening visit & baseline visit
- •4.Subject provides written informed consent and comes for regular follow up
排除标准
- •1.Subjects with major psychiatric disorders
- •2.Subjects having a history of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •3.Subject has a history of diabetes
- •4.Subject has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery.
- •5.Subject has an anatomical deformity of the penis which has a severe effect on sexual functioning
- •6.Subject is a k/c/o HIV or AIDS
- •7.Subject is know to suffer from STDs at screening visit
- •8.Subject is a chronic alcoholic showing withdrawal symptoms or subjects having medication (opiates etc) or drug (marijuana, cocaine etc)/ Nicotine/Caffeine dependence
- •9.Subject is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, β-adrenergic blockers, anti- depressants etc.)
- •10.Subject has a major illness that in the opinion of the investigator would interfere with the conduct of the study.
- •11.Subject has participated in a clinical drug study within the last 30 days prior to entering this study.
- •12.Subject with Liver dysfunction as evidenced by SGPT level of 1.5 X ULN.
- •13.Subject with Renal dysfunction as evidenced by Serum Creatinine level of 1.5 X ULN.
- •14.Subject has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN.
- •15.Subject has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl).
- •16.Subjects already taking any medications for the study indication & do not wish to discontinue the same
- •17.Subject not ready to sign the consent & unable to comply with the protocol
- •18.Subjects whose female partners are Pregnant
研究者
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