Clinical study on IMPERIMÂ® Capsule in erectile dysfunction.

Phase 2

Completed

Conditions: Health Condition 1: N529- Male erectile dysfunction, unspecified

Registration Number: CTRI/2019/09/021217

Lead Sponsor: Dr Bioveda Lab

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

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

5.Subjects willing to make all required study visits

6.Subjects willing to follow study instructions given by the investigator

Exclusion Criteria

1.Subjects with major illnesses and sexual dysfunction due to anatomical surgical or pharmacological causes

2.History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity

3.Presence of any drug or therapy that may have relation with ED and sexual dysfunction

4.Subjects with total erectile failure or any other sexual disorder, hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma

5. Subjects with preexisting systemic disease necessitating long-term medications

6.Continuing history of alcohol and or drug abuse

7.Subjects with significant abnormal laboratory parameters

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assessment of erectile function of penis on Erectile function subscale of IIEF Questionnaire <br/ ><br>2.Hardness of penis on Erection Hardness Score (EHS) <br/ ><br>Timepoint: Day -3, Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Sexual desire or Libido and other parameters on IIEF <br/ ><br>2.Assessment of Male sexual health on EDITS questionnaire <br/ ><br>3.Assessment of Quality of Sexual life on Sexual Quality of Life Questionnaire <br/ ><br>4.Assessment of Changes in serum testosterone <br/ ><br>5.Assessment of Drug compliance <br/ ><br>6.Global assessment for overall change by investigator and patient <br/ ><br>7. Tolerability of study drug by assessing adverse events and laboratory parameters. <br/ ><br>Timepoint: Day -3, Day 0, Day 15, Day 30