None listed
Conditions
Interventions
Intervention1: Gremin 500mg: Oral Administration of single 500 mg Gremin capsule once a day for 14 days
Control Intervention1: Placebo 500mg: Oral Administration of single 500 mg Placebo capsule Once
Sponsors
ZeusHygia LifeSciences Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Moderate physically active (regular aerobic exercise for at least 2-3 hours per week) 2. Body Mass Index (BMI) = 30 kg per m2 3. Subjects with no known musculoskeletal pathology 4. Subjects who are non-smokers 5. Female subjects of childbearing age, agree to use approved birth control methods during the study and have a negative urine pregnancy test (UPT) at screening 6. Subjects willing to adhere to their routine diet, physical activity, and general lifestyle throughout the study 7. Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1. Subjects currently on or taken in the prior month any anti-inflammatory or analgesic or antioxidant drugs 2. Subjects having symptoms of viral infection 3. Subjects with history of abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious process and presence of any known disease in last 3 months. 4. Subjects with history of - Uncontrolled or serious medical illness including diabetes, liver disease, hypertension - Cardiac Disease or Neurological Problems - Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes) - Gastrointestinal tract bleeding or peptic ulcer disease - Psychiatric disorders or current alcoholism or drug abuse - Drug abuse, smoking, abuse or addiction to alcohol - Eating disorder such as bulimia or binge eating - Endocrine abnormalities including stable thyroid disease - Any major surgery, including cardiovascular surgery and surgery of oesophagus, stomach or duodenum, bariatric surgery 5. Subjects with open wounds 6. Subjects with injury involving skeletal system or deep soft tissue injury in last 3 months 7. Subjects on steroids or ergogenic users since past 3 months 8. Subjects who maybe allergic to any of the natural constituents of the Investigational Product 9. Pregnant and lactating women 10. Known HIV or Hepatitis B positive or any other immuno-compromised state 11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 12. Any additional conditions that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in endurance, Isometric muscle strength and fatigueTimepoint: Baseline, Day 7, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BiomarkersTimepoint: Baseline, Day 7, Day 14 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed