Clinical study on JPF-16 Capsules in Sexual Dysfunction in Females
- Conditions
- Health Condition 1: null- Female Sexual Dysfunction
- Registration Number
- CTRI/2017/06/008791
- Lead Sponsor
- Chatarubhuj Pharmaceutical Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. 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
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)] <br/ ><br> <br/ ><br>Timepoint: Day -7, Day 0, Day 14 and Day 28 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Global assessment for overall improvement by the patient at the end of the study treatment. <br/ ><br>2. Global assessment for overall improvement by the investigator at the end of the study treatment. <br/ ><br>3. Assessment of Tolerability of study drug by assessing ADRs on study completion. <br/ ><br>4. Assessment of Laboratory parametersTimepoint: Day -7, Day 0, Day 14 and Day 28 <br/ ><br>