CTRI/2009/091/000012已完成2 期
A triple blind, randomized, double dummy, prospective placebo controlled dose determination study to investigate the safety and efficacy of E-MA-H and E-MA-HP capsules as a dietary supplement for Male Sexual Health.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
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.Males aged between 21-60 yrs
- •2.Subject having a monogamous, heterosexual relationship
- •3.Subject satisfying any one of the following criteria.
- •a. Subject having Erectile dysfunction IIEF A Score in between 11-21
- •b. Premature Ejaculation IPE Score in between 18-28
- •c. Other sexual dysfunction IIEF B Score in between 21-30
排除标准
- •1.Subjects taking herbal or Ayurvedic/Herbal treatment in the last 15 days (Only for Male Sexual Dysfunction).
- •2.Subjects taking any other treatment in the last 7 days (Only for Male Sexual Dysfunction).
- •3.Subjects with major psychiatric disorders or severe systemic disorders
- •4.History of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia or spinal cord injury within the past 6 months.
- •5.Subject having uncontrolled diabetes mellitus and/or h/o diabetes mellitus for more than 10 years.
- •6.H/o Male Sexual Dysfunction more than six months in diabetic subjects.
- •7.Anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or phimosis.
- •8.K/C/O HIV Positive and AIDS
- •9.Has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN.
- •10.Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl).
- •11.Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates).
- •12.Is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc).
- •13.Subject has participated in any clinical trial within last 30 days.
- •14.Subjects not ready to sign the consent & unable to comply with the protocol.
研究者
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