CTRI/2020/11/028782已完成未知
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 - CT-AKJ-01- 2020
DrSankalp Jain0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- •Male subjects between 18 to 64 years of age.
- •2. Male subjects with stable, monogamous, heterosexual relationship for
- •at least 6 months and expected/planned to maintain this relationship
- •for duration of study.
- •3. 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).
- •4. 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: 565-573.
- •5. Subject and his partner agreeing to attempt sexual intercourse 2
- •times/ week.
- •6. Subject willing to give written informed consent and willing to comply
- •with trial protocol.
排除标准
- •1. Previous events or other conditions associated with premature
- •ejaculation/erectile dysfunction including but not limited to spinal
- •trauma or pelvic surgery.
- •2. Subjects with genital anatomical deformities including but not limited
- •to penile deformities.
- •3. Subjects with erectile dysfunction or premature ejaculation due
- •medication withdrawal.
- •4. Sexual dysfunction in female partner, painful intercourse, partners
- •with decreased interest in intercourse or other forms of sexual
- •dysfunction.
- •5. Subjects with major psychiatric illness or previous suicidal attempts.
- •6. Subjects with history of epilepsy
- •7. Subjects with history of stroke, myocardial infraction, heart failure,
- •unstable angina, life-threatening arrhythmia and hypotension with in
- •past 6 months.
- •8. Subjects for whom sexual activity is inadvisable because of their
- •underlying disease status.
- •9. Subject is a known case of autonomic neuropathy, retinitis
- •pigmentosa, bleeding disorders, sickle cell anemia and active peptic
- •ulcer disease.
- •10. Subjects with significant and uncontrolled hematological/metabolic/
- •endocrinologial/respiratory/cardiovascular/neurological/psychiatric
- •/liver/kidney diseases.
- •11. Subjects with resting hypotension (BP 90/50) or hypertension ( BP
- •Proprietary and confidential informat
研究者
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