Clinical study on JPF-16 Capsules in Sexual Dysfunction in Females

Phase 2/3

Completed

• Conditions: Female Sexual Dysfunction

• Registration Number: CTRI/2017/06/008791
• Lead Sponsor: Chatarubhuj Pharmaceutical Co

Brief Summary

Itis an open label, interventional, multi-center, prospective clinical study toevaluate efficacy and safety of ‘JPF-16 Capsule’ in 38 female patientssuffering from sexual dysfunction. The study will be conducted at two sites inIndia. The dose of the drug would be 2 capsules two times daily orally aftermeals for 4 weeks. The primary outcome measures will be to assess efficacy of ‘JPF-16Capsule’ on sexual feelings and responses [assessment using Female Sexual FunctionIndex (FSFI)] on day -7, day 0, day, 14 and day 28. The secondary outcomes willbe assessment of Global assessment for overall improvement by the investigatorand by the patient at the end of the study treatment, assessment oftolerability of study drug by assessing adverse events and assessment oflaboratory parameters on day -7, day 0, day 14 and day 28

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-05
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of Female Sexual Interest/Arousal Disorder according to the DSM-5 criteria (2013) 2.
• Be involved in a stable relationship and have a partner 3.
• Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant.

Exclusion Criteria

1.Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes 2.Subjects with history of major psychiatric disorder 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sexual feelings and responses [assessment using Female Sexual Function Index (FSFI)]	Day -7, Day 0, Day 14 and Day 28

Secondary Outcome Measures

Name	Time	Method
1. Global assessment for overall improvement by the patient at the end of the study treatment.	2. Global assessment for overall improvement by the investigator at the end of the study treatment.

Trial Locations

Locations (2)

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

Shri Gurudeo Ayurved College and Hospital Amravati; 🇮🇳 Amravati, MAHARASHTRA, India

KVTR Ayurvedic College Boradi

🇮🇳Dhule, MAHARASHTRA, India

Dr Narendrakumar Bhanudas Mundhe

Principal investigator

09850378206

drnbmundhe@gmail.com