Clinical study on JP-16 Capsules in impotency

Phase 2/3

Completed

• Conditions: erectile dysfunction

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

Brief Summary

Itis an open label, interventional, multi-center, prospective clinical study toevaluate efficacy and safety of ‘JP2016 Capsule’ in 40 patients suffering frommild to moderate erectile dysfunction. The study will be conducted at two sites in India. The dose of the drug would be2 capsules two times daily orally after meals for 30 days. The primary outcomemeasures will be to assess efficacy of ‘JP2016 Capsule’ on erectile function ofpenis using Erectile function subscale of IIEF Questionnaire, and to assesshardness of penis on Erection Hardness Score (EHS) on day 0, day, 15 and day30. The secondary outcomes will be to assess efficacy of ‘JP2016 Capsule’ onMale sexual health on EDITS questionnaire (Patient & Partner version), onQuality of Sexual life on Sexual Quality of Life Questionnaire (SQoL-M), onChanges in serum testosterone levels (Free and Total), assessment of sexualencounter profile as per the recordings in daily diary card, assessment of drugcompliance, assessment of Global assessment for overall improvement by theinvestigator and by the patient at the end of the study treatment, assessmentof tolerability of study drug by assessing adverse events and assessment oflaboratory parameters on day 0, day 15 and day 30

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-18
• Study Completion: 2016-08-25
• Last Update Posted: 2017-04-09

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
• Subject without any organic cause of Sexual Dysfunction.
• Subjects should be in an active stable sexual relationship for the duration of study.

Exclusion Criteria

• 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
2.To evaluate efficacy of JP2016 Capsule on Hardness of penis on Erection Hardness Score	Day -3, Day 0, Day 15 and Day 30
1.To evaluate efficacy of JP2016 Capsule 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.To evaluate efficacy of JP2016 Capsule on Male sexual health on EDITS questionnaire	2.To evaluate efficacy of JP2016 Capsule by assessing Changes in serum testosterone levels

Trial Locations

Locations (2)

KVTR Ayurvedic College Boradi; 🇮🇳 Dhule, MAHARASHTRA, India

MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra; 🇮🇳 Pune, MAHARASHTRA, India

KVTR Ayurvedic College Boradi

🇮🇳Dhule, MAHARASHTRA, India

Dr Narendrakumar Bhanudas Mundhe

Principal investigator

09850378206

drnbmundhe@gmail.com