Health Condition 1: null- Erectile Dysfunction
Conditions
Interventions
Intervention1: AHPL/AYCAP/0114 capsule: It contains Gokshura Extract (Tribulus terrestris), Ashvagandha Extract (Withania somnifera), Shvet musali Extract (Asparagus adscendens), Kapikacchu Extract (M
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male subjects aged 21-50 years suffering from ED for more than 6 months. 2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit. 3.Subjects should be in an active stable sexual relationship for the entire duration of study 4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects having anatomical abnormalities of the penis. 2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs. 3.Patients having unstable angina pectoris, myocardial infarction, stroke, chronic renal and liver diseases, uncontrolled diabetes mellitus and hypertension. 4.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs. 5.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion. 6.Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases 7.Patients receiving corticosteroids and diuretics. 8.Any major disease that in investigatorâ??s opinion may interfere with male sexual health. 9.Known hypersensitivity to ingredients used in study drug 10.Subjects with significant abnormal laboratory parameters 11.ECG demonstrating any signs of uncontrolled arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Erectile function domain of IIEF QuestionnaireTimepoint: Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Changes in Orgasmic function, Sexual desire, Intercourse satisfaction, Overall satisfaction domain scores of IIEF Questionnaire â?¢Changes in Hardness of Penis â?¢Changes in Male Sexual Health â?¢Assessment of sexual encounter profile â?¢Assessment of overall improvement in male sexual health at the end of treatment by patient and physician. â?¢Changes in Serum total testosterone levels. â?¢Adverse events assessment â?¢Post treatment changes in laboratoryTimepoint: Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed