CTRI/2017/08/009425
Completed
Phase 2
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 sites38 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Welex Laboratories Pvt Ltd
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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