None listed
Conditions
Interventions
Intervention1: Shilogenixâ?¢ Pre workout and Post workout Capsules (500 mg and 750 mg): Oral administration of Shilogenix capsules 500 mg or 750 mg as per assigned study arm. One capsule to be taken w
Sponsors
Umalaxmi Organics Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male participants of 25-40 years age who are willing to sign the informed consent document and comply with all other protocol requirements. 2. Participants should be engaged in regular physical activity 6 days per week, for a minimum of 60 minutes each day. 3. Physical activity can include workouts at the gym or home, running, cycling, brisk walking, strength training, sports, or any other moderate to vigorous exercise. 4. Trial participants with BMI greater than or equal to 18.5 and less than or equal to 27.5 kg/m2. 5. Trial participants who are ready to abstain from alcohol, smoking and caffeine for 24hrs before every study visit.
Exclusion criteria
Exclusion criteria: 1. Trial participants having blood hemoglobin levels less than 12.0 g per deciliter at the time of screening. 2. Trial participants with oxygen saturation less than 96 percent at the time of screening. 3. Trial participants with random blood glucose levels greater than or equal to 140 milligrams per deciliter at the time of screening. 4. Any clinically significant electrocardiogram abnormality at screening, such as corrected QT interval greater than 450 milliseconds in males, abnormal heart rhythm, or signs of heart abnormalities as per investigatorâ??s opinion. 5. Trial participants who have been using nutritional or energy supplements, medications, or steroids to enhance physical performance within the past 30 days. 6. Trial participants with a history of uncontrolled diabetes or hypertension. 7. Trial participants with any unstable medical illness including but not limited to cardiovascular, renal, or hepatic disorders at screening. 8. Trial participants with a history of any medical condition where exercise is contraindicated. 9. Trial participants who are currently on diuretics. 10. Trial participants who have donated blood within one month prior to screening. 11. History of any orthopedic injury or surgery that incapacitates the participant for exercise. 12. Any planned participation in any sporting event during the study period. 13. Trial participants with a known history of allergies or hypersensitivity to Shilajit. 14. Trial participants who have recently participated in a clinical trial within the last three months. 15. Any other medical condition or medication which, in the opinion of the investigator, may interfere with the study results or jeopardize the health of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change from baseline in muscular strength as assessed by One Repetition Maximum testing. 2.Mean change from baseline in maximal oxygen uptake assessed using Bruce protocol treadmill testing. 3. Mean change from baseline in submaximal endurance performance assessed using a standardized treadmill based submaximal exercise test. 4. Mean change from baseline in time to fatigue during continuous treadmill exercise at a predetermined workload until volitional exhaustion. 5. Mean change from baseline in perceived fatigue assessed using the Fatigue Assessment Scale. 6. Mean change from baseline in exercise induced muscle soreness assessed using a Visual Analog Scale. 7. Mean change from baseline in body weight. 8. Mean change from baseline in body composition indices including lean body mass and body fat percentage assessed via standardized skinfold thickness measurements using calibrated callipersTimepoint: Baseline Week 01 Week 02 Week 04 Week 06 Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change from baseline in male reproductive hormonal profile including total testosterone, free testosterone, follicle stimulating hormone, luteinizing hormone, and prolactin. 2. Mean change from baseline in semen analysis parameters. 3. Mean change from baseline in lipid profile parameters. 4. Mean change from baseline in systemic inflammatory marker C reactive protein. 5. Mean change from baseline in physiological stress biomarker serum cortisol. 6. Incidence and severity of adverse events and treatment emergent adverse events. 7. Changes in hematological, hepatic, and renal function markers including complete blood count, liver function tests, and renal function tests.Timepoint: 1. Hormonal profile: Screening, Week 01, Week 06, Week 10 2. Semen analysis: Screening, Week 06, Week 10 3. Lipid profile: Screening, Week 10 4. C reactive protein: Screening, Week 06, Week 10 5. Serum cortisol: Screening, Week 06, Week 10 6. Adverse events: Throughout the study 7. Laboratory parameters including complete blood count, liver function tests, and renal function tests: Screening and Week 10 | — |
Countries
India
Contacts
Public ContactMr Jeetesh Dave
Eccentric Clinical Research Private Limited
Outcome results
None listed