跳至主要内容
临床试验/CTRI/2017/08/009425
CTRI/2017/08/009425已完成2 期

An open label, interventional, multi-center, prospective clinical study to evaluate efficacy and safety of â??Ayuvigo Forte Capsuleâ?? in patients suffering from mild to moderate erectile dysfunction - NI

Welex Laboratories Pvt Ltd0 个研究点目标入组 38 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
38

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. Subjects who have scored 13 to 24 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
  • 2. Subject without any organic cause of Erectile Dysfunction.
  • 3. Subjects should be in an active stable sexual relationship for the duration of study
  • 4. Subject willing to participate in clinical trial and who have read, understood and signed informed consent form

排除标准

  • 1. Subjects with total erectile failure or any other sexual disorder
  • 2. Subjects with history of disorders that may cause priapism
  • 3. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
  • 4. Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
  • 5. Subjects who are using and or dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Ayurvedic, herbal, homeopathic, naturopathy medications for erectile dysfunction
  • 6. Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders
  • 7. Continuing history of alcohol and or drug abuse
  • 8. ECG demonstrating any signs of uncontrolled arrhythmia, acute ischemia and X- ray chest showing any active lesion of tuberculosis
  • 9. Subjects with significant abnormal laboratory parameters

研究者

发起方
Welex Laboratories Pvt Ltd

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