Health Condition 1: F520- Hypoactive sexual desire disorder
Conditions
Interventions
Intervention1: Punarvita Sachet 6 point 75 gm along with Standard of Care: Pateint will receive Punarvita Sachet 6 point 75 grams once daily for 12 weeks
Control Intervention1: Placebo along with Sta
Sponsors
MONTOSUN BIOPHARMA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male participants aged between 21 to 50 years at the time of screening 2 Male participants with mild to moderate sexual dysfunction of 3 months duration or longer associated with functional impairment or distress defined by a Sexual Health Inventory for Men SHIM score of 8 to 21 inclusive at screening Participants must be sexually active or willing to engage in sexual activity during the study period 3 Willing to undergo hormonal assessments and semen analysis as required by the study protocol and having normal reproductive hormonal levels at screening for example serum testosterone FSH LH and prolactin within the laboratory reference range 4 Able and willing to provide written informed consent prior to participation in any study related procedures 5 Willing and able to comply with all study procedures visit schedules and protocol requirements in the opinion of the investigator
Exclusion criteria
Exclusion criteria: 1 Presence of severe erectile dysfunction requiring immediate pharmacological or medical intervention 2 Known infertility due to irreversible medical or anatomical causes 3 Clinically significant endocrine disorders for example uncontrolled diabetes mellitus HbA1c greater than 8 percent thyroid dysfunction hyperprolactinemia or pituitary disorders that may affect sexual function hormonal status or study outcomes History of prostate cancer or clinically significant urological disorders 4 Presence of severe psychiatric illness or psychological conditions that may affect participation or study assessments 5 Clinically significant cardiovascular hepatic or renal disease that may pose a safety risk or interfere with study participation 6 Use of testosterone therapy anabolic steroids or hormonal treatments within the last 3 months prior to screening 7 Use of fertility treatments or medications affecting spermatogenesis within the last 3 months prior to screening 8 Known hypersensitivity or allergy to any component of the study product 9 Participation in another clinical trial or investigational study within 30 days prior to screening 10 Any medical condition or circumstance that in the opinion of the investigator may compromise participant safety or interfere with study participation or interpretation of results 11 History of alcohol or substance abuse 12 Severe obesity defined as body mass index BMI 35 kg per square meter or greater at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sexual wellbeing as assessed by a validated questionnaire Sexual Health Inventory for Men SHIMTimepoint: from baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hormonal parameters including serum total testosterone free testosterone luteinizing hormone follicle stimulating hormone prolactin sex hormone binding globulin and estradiol levels Change in semen parameters including sperm concentration sperm count total and progressive sperm motility sperm morphology and semen volume assessed according to standardized semen analysis procedures Change in erectile function intercourse satisfaction and orgasmic function domain scores as assessed using the validated International Index of Erectile Function questionnaire Participant Global Assessment of improvement Investigator Global Assessment of improvementTimepoint: from baseline to week 12 | — |
Countries
India
Contacts
Public ContactChandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed