None listed
Conditions
Interventions
None listed
Sponsors
Eetho Brands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 19 to 60 years of age 2. Adult subjects with good health, as determined by a health history and at the Investigators discretion. 3. Subject willing to participate and able to comply with the protocol. 4. Subjects who provide written, signed, and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with a sleep disorder or a history of clinical depression, eating disorders, or other psychiatric conditions. 2. Subjects with a history or current presence of health conditions, including abnormal resting ECG, bleeding disorder, diabetes, high blood pressure, thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 3. Participants using medications - anti-inflammatory, analgesic, antioxidant drugs, nutritional products, and dietary supplements that may interfere with the study results, as determined by the investigators opinion. 4. History of allergy or sensitivity to any ingredient in the test product, as well as a history of alcohol or other drug abuse within the last year. 5. Participation in another clinical study within the past 30 days. 6. Subjects with a history of orthopaedic injury or surgery within the last year. 7. Presence of any physical condition considered a contraindication to the type of exercise to be performed in the study. 8. Subjects who do not agree to participate or are not capable of complying with protocol requirements. 9. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the trial period in Improvement in the stabilization of muscles or a reduction in the degree of muscle fatigue measured by an increase in VO2 max (treadmill)Timepoint: Baseline (Day 0), Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the levels of C-reactive protein from baseline to end of the studyTimepoint: Baseline (Day 0), Day 15 and Day 30;Change in vital sign parameters from baseline to end of the studyTimepoint: Baseline (Day 0), Day 15 and Day 30;Incidence of adverse events during study periodTimepoint: Day 15 and Day 30;SF 36 – QOL – Vitality scaleTimepoint: Baseline (Day 0), Day 15 and Day 30;Change from baseline to end of the trial period in Decrease in levels of Creatine Kinase (CK) assessed by the oxidative stress and inflammatory marker test (Hs CRP)Timepoint: Baseline (Day 0), Day 15 and Day 30;Change from baseline to end of the trial period in Global assessment of overall improvement from baseline to end of the study (SGA and PGA)Timepoint: Baseline (Day 0), Day 15 and Day 30;Change from baseline to end of the trial period in Reduction in pain score, identified using the Visual Analog Scale (VAS).Timepoint: Baseline (Day 0), Day 15 and Day 30;Change in laboratory safety parameters (haematological parameters, liver function, kidney function and blood lipid profile parameters) from baseline to end of the study.Timepoint: Screening and EOT | — |
Countries
India
Contacts
Public ContactDr Venkateshwarlu K
GREEN MEDIC SOLUTION
Outcome results
None listed