Clinical study on Ayuvigo Forte Capsule in erectile dysfunction

Phase 2

Completed

Brief Summary: Itis an open label, interventional, multi-center, prospective clinical study toevaluate efficacy and safety of â€˜Ayuvigo Forte Capsuleâ€™ in 38 patientssuffering from mild to moderate erectile dysfunction. The study will be conductedat two sites in India. The dose of thedrug would be 2 capsules three times daily orally after meals for 30 days. Theprimary outcome measures will be to assess efficacy of Ayurvigo Forte Capsuleon erectile function of penis using Erectile function subscale of IIEFQuestionnaire, and to assess hardness of penis on Erection Hardness Score (EHS)on day 0, day, 15 and day 30. The secondary outcomes will be to assess efficacyof Ayurvigo Forte Capsule on Male sexual health on EDITS questionnaire (Patient& Partner version), on Quality of Sexual life on Sexual Quality of LifeQuestionnaire (SQoL-M), on Changes in serum testosterone levels (Free andTotal), assessment of sexual encounter profile as per the recordings in dailydiary card, assessment of drug compliance, assessment of Global assessment foroverall improvement by the investigator and by the patient at the end of thestudy treatment, assessment of tolerability of study drug by assessing adverseevents and assessment of laboratory parameters on day 0, day 15 and day 30

Recruitment & Eligibility

Inclusion Criteria

Subjects who have scored 13 to 24 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
Subject without any organic cause of Erectile Dysfunction.
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

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 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.

Primary Outcome Measures

Name	Time	Method
2. Efficacy of Ayurvigo Forte Capsule on Hardness of penis on Erection Hardness Score (EHS)	Day -3, Day 0, Day 15 and Day 30
1.Efficacy of Ayurvigo Forte Capsule on erectile function of penis on Erectile function subscale of IIEF Questionnaire	Day -3, Day 0, Day 15 and Day 30

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Male sexual health on EDITS questionnaire	2.Assessment Quality of Sexual life on Sexual Quality of Life Questionnaire

Locations (2): Government Ayurved College, Wajirabad,Nanded
🇮🇳
Nanded, MAHARASHTRA, India
KVTR Ayurvedic College Boradi
🇮🇳
Dhule, MAHARASHTRA, India
Government Ayurved College, Wajirabad,Nanded
🇮🇳Nanded, MAHARASHTRA, India
Dr Vishwas Gogte
Principal investigator
9422214311
vishwas_eknath@yahoo.in