IRCT2016122931645N1招募中3 期
Effect of local traditional medicine product based on Nigella Sativa on premature ejaculation -A ranomized triple blind placebo controlled traial
trita company0 个研究点目标入组 76 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
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
- 年龄范围
- 75 years 至 55 years（—）
- 性别
- Male
入选标准
- •1. The men 20 to 40 years old.
- •2. Steady sexual activity at least 6 month with a female partner.
- •3. The history of premature ejaculation more than 6 months.
- •4. Time IELT less than 1 minute.
- •5. The ability to begin and maintain an erection (IIEF score of 22).
- •6. Sexual intercourse at least one time per week.
- •7. Informed consent of patient to entering the project and filling the consent form from him.
- •1. A history of severe organic diseases such as uncontrolled diabetes, heart failure, acute renal failure, urinary surgery, urinary tract infections in male and partner.
- •2. A history of severe psychiatric illness and poor mental state.
- •3. PEDT questionnaire score less than 11.
- •4. The history of alternate premature ejaculation.
- •5. Erectile Dysfunction (IIEF score less than 22)
- •6. Anatomic abnormalities of the penis that causes unsuccessful penetration.
- •7. Substance abuse such as alcohol, opium and smoking.
- •8. Using drugs that affect the sexual function, including phosphodiesterase inhibitors and selective serotonin reuptake inhibitors and opioids and antidepressants and anti-anxieties and hormonal drugs during project.
- •9. Extreme hot and dry temperament.
- •10. The warm and wet temperament with semen acuity.
- •11. Any history of hypersensitivity to black cumin, frankincense and olives.
- •12. The history of any type of mucosal and dermal allergy.
- •Exclusion criteria:
- •1. using of drugs and substance that effective on sexual performance.
- •2. Intercourse activity less than twice in three weeks.
- •3. The using of condom and local anesthetic.
- •4. The sever decrease in male libido or sexual partner.
- •5. The use of any vaginally cream, ointment or gel by partner.
- •6. Severe and intolerable adverse events associated with the drug based on a questionnaire PRO- CTCAE.
- •7. The Withdrawing of participant from continuing the project with any reason.
排除标准
- 未提供
研究者
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