Health Condition 1: F520- Hypoactive sexual desire disorder
Conditions
Interventions
None listed
Sponsors
Greenspace
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged 30 to 55 years. 2. History of low libido and/or erectile dysfunction (diagnosed or self-reported, greater than or equal to 3 months), as defined by an International Index of Erectile Function (IIEF-15) score less than or equal to 21. 3. History of smoking (current or former smokers with at least 1 5 cigarettes per day). 4. Diagnosed with early-onset Type 2 Diabetes Mellitus (diagnosis before the age of 45, with current HbA1c between 6.5 percentage and 8.5 percentage) within the last 6 months. 5. Moderate to high perceived stress, defined by a score greater than or equal to 14 on the Perceived Stress Scale (PSS-10). 6. Willing and able to provide written informed consent. 7. Willing to comply with all study-related procedures and assessments for the full duration of the study. 8. Stable dose of ongoing medications for Chronic ailments (e.g., antidiabetic, antihypertensive) for the past 3 months
Exclusion criteria
Exclusion criteria: 1. Severe ED due to anatomical or neurological causes (e.g., spinal cord injury, post-prostatectomy). 2. Use of PDE-5 inhibitors or other ED medications in the past 4 weeks. 3. Uncontrolled T2DM (HbA1c greater than 8.5 percentage) or recently initiated antidiabetic therapy (within 3 months). 4. History of myocardial infarction, stroke, or unstable angina within the last 6 months. 5. Hypogonadism or androgen deficiency, defined by serum testosterone less than 200 ng/dL. 6. Psychiatric disorders (e.g., severe depression, psychosis) requiring medication. 7. Known hepatic or renal impairment (ALT or AST greater than 2.5 ULN, eGFR less than 60 mL/min). 8. Any active malignancy or treatment for cancer within the last 12 months. 9. Known allergy or hypersensitivity to any component of the supplement capsule. 10. Participation in another investigational study within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in libido and/or erectile function assessed by the International Index of Erectile Function (IIEF-15) questionnaire.Timepoint: From baseline to end of study (90 Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in nitric oxide levels (pre- and post-intervention)Timepoint: Changes in nitric oxide levels (pre- and post-intervention): - Time Frame: Day -2 to -1, Day 90;Changes in serum TNF-alpha and IL-6 levels (inflammatory biomarkers)Timepoint: Changes in inflammatory biomarkers: - Interleukin-6 (IL-6) Changes. - Tumor Necrosis Factor-alpha (TNF-alpha) Changes. Time Frame: Day -2 to -1, Day 90;Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS).Timepoint: Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS): - PSS-10. Time Frame: Day -2 to -1, Day 30 Day 90;Changes in serum testosterone levels (total and free)Timepoint: Changes in serum testosterone levels (total and free): Time Frame: Day -2 to -1, Day 90;Safety evaluated via adverse event monitoring and laboratory assessmentsTimepoint: Safety Endpoints: - Adverse Events: Incidence of treatment-emergent adverse events (TEAEs) will be monitored. - SAEs: Identification and documentation of any serious adverse events that occur during the study, requiring immediate medical attention or hospitalization - Vital Signs: Monitoring of participants vital signs (blood pressure, heart rate, respiratory rate, temperature) to assess any significant weight changes during the trial. Time Frame: Day -2 to -1, Day 30, Day 90 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd.
Outcome results
None listed