Health Condition 1: null- Mild to moderate erectile dysfunction
Conditions
Interventions
Intervention1: Ayuvigo Forte Capsule: It contains Mucuna pruriens, Withania somnifera, Tribulus terrestris, Sida cordifolia and Shilajeet.
Dosage and Treatment Duration: 2 capsules thrice daily orall
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Efficacy of Ayurvigo Forte Capsule on erectile function of penis on Erectile function subscale of IIEF Questionnaire 2. Efficacy of Ayurvigo Forte Capsule on Hardness of penis on Erection Hardness Score (EHS)Timepoint: Day -3, Day 0, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of Male sexual health on EDITS questionnaire 2.Assessment Quality of Sexual life on Sexual Quality of Life Questionnaire 3.Assessment of Changes in serum testosterone levels (Free and Total) 4.Assessment of sexual encounter profile as per the recordings in daily diary card 5.Drug compliance 6.Global assessment for overall improvement by the investigator and by the patient 7.Tolerability of study drug by assessing adverse events 8.Laboratory parametersTimepoint: Day -3, Day 0, Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed