Clinical study on JP-16 Capsules in impotency

Phase 2

Completed

• Conditions: Health Condition 1: null- erectile dysfunction

• Registration Number: CTRI/2017/09/009618
• Lead Sponsor: Chatarubhuj Pharmaceutical Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-08-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.

2. Subject without any organic cause of Sexual Dysfunction.

3. Subjects should be in an active stable sexual relationship for the duration of study

Exclusion Criteria

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

2. Subjects with total erectile failure or any other sexual disorder

3. Subjects with history of disorders that may cause priapism

4. Subjects with history of major psychiatric disorder

5. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery

6. Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate efficacy of JP2016 Capsule Erectile function of penis on Erectile function subscale of IIEF Questionnaire <br/ ><br> <br/ ><br>2.To evaluate efficacy of JP2016 Capsule on Hardness of penis on Erection Hardness ScoreTimepoint: Day -3, Day 0, Day 15 and Day 30

Secondary Outcome Measures

Name	Time	Method
1.To evaluate efficacy of JP2016 Capsule on Male sexual health on EDITS questionnaire <br/ ><br>2.To evaluate efficacy of JP2016 Capsule by assessing Changes in serum testosterone levels <br/ ><br>3.To evaluate efficacy of JP2016 Capsule on Global assessment for overall improvement by the investigator and by the patient at the end of the study treatment <br/ ><br>4.To evaluate Tolerability of JP2016 Capsule <br/ ><br>5.Adverse events <br/ ><br>6.Laboratory parametersTimepoint: Day -3, Day 0, Day 15 and Day 30