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
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进行中(未招募)
不适用
One cohort Study To Assess the duration of the improvement following NOVA22007 Treatment Discontinuation in Improved Patients With Severe Dry Eye Disease.EUCTR2012-002066-12-ATOVAGALI Pharma S.A.S130
进行中(未招募)
不适用
One cohort Study To Assess the duration of the improvement following NOVA22007 Treatment Discontinuation in Improved Patients With Severe Dry Eye Disease.Severe Dry Eye DiseaseMedDRA version: 14.1Level: LLTClassification code 10023350Term: Keratoconjunctivitis siccaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disordersEUCTR2012-002066-12-GBOVAGALI Pharma S.A.S130
