None listed
Conditions
Interventions
Intervention1: Group A: Two Shilajit gummies in sequence once daily after a major meal for 90 days.
Control Intervention1: Group B: Two Placebo gummies in sequence once daily after a major meal for 90
Sponsors
Mosaic Wellness Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged 45-55 years (both inclusive) with BMI not more than 30 kg per meter square 2. Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit 3. Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III) -serum triglycerides: greater than or equal to 150 mg per dL, HDL cholesterol- less than or equal to 40 mg per dL in men, blood pressure- greater than or equal to 130 mm Hg systolic or greater than or equal to 85 mm Hg diastolic, fasting plasma glucose greater than or equal to 100 mg per dL, Abdominal obesity, waist circumference: men greater than 90 cm 4. Participants should be in an active stable sexual relationship for the entire duration of the study 5. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous events or other severe conditions that may affect sexual health or metabolic health 2. Participants with genital anatomical deformities, including but not limited to penile deformities 3. Participants for whom sexual activity is inadvisable because of their underlying disease status 4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals 5. Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical trial outcomes 6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs 7. Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year 8. Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day 9. Any concomitant treatment that is not permissible including but not limited to nitrates, anti androgens, chemotherapy agents, radiotherapy, etc. 10. Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol 11. Known hypersensitivity to any of the ingredients of the investigational product 12. Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceuticals, or ayurvedic supplement for sexual health & well-being 13. Participants consuming any nutraceutical, herbal, or ayurvedic supplement for any other condition 14. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in free testosterone and total testosterone levels 2.Changes in libido system score (LSS) score. 3.Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) score. 4.Metabolic Syndrome Severity Z Score (MetZ score). MetZ score is derived from five key components of Metabolic Syndrome (waist circumference, triglycerides, HDL cholesterol, systolic blood pressure, and fasting plasma glucose) 5.Changes in cardiorespiratory endurance by VO2 max by step test.Timepoint: screening, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in anthropometric parameters including body weight (kg), waist circumference and BMI. 2. Changes in Fatigue Severity Scale (FSS) score. 3. Changes in energy levels assessed by energy audit diary. 4. Changes in Profile of Mood State (POMS) questionnaire score. 5. Changes in perceived stress scale-10 (PSS-10) score.Timepoint: 1. at screening, day 30, day 60 and day 90 2. at screening, day 30, day 60 and day 90 3. at screening, day 30, day 60 and day 90 4. at screening and day 90 5. at screening, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactShreyans Jain
Mosaic Wellness Pvt Ltd
Outcome results
None listed