Health Condition 1: null- Female Sexual Dysfunction
Conditions
Interventions
Intervention1: JPF-16 Capsule: JPF-16 Capsule contains Kapikacchu, Ashvagandha, Keshar, Akarkara, Shvet Musali, Shilajit, Ashok, Lodhra, Pradrantak loha, Puspadhanwa ras and others
Dosage and Treatm
Sponsors
Chatarubhuj Pharmaceutical Co
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sexual feelings and responses [assessment using Female Sexual Function Index (FSFI)] Timepoint: Day -7, Day 0, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3. Assessment of Tolerability of study drug by assessing ADRs on study completion. 4. Assessment of Laboratory parametersTimepoint: Day -7, Day 0, Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed