None listed
Conditions
Interventions
Intervention1: NRAHG001 capsule: 30 mg capsule once daily in the morning either before or after food for 56 days.
Control Intervention1: Placebo: 30 mg capsule once daily in the morning either before
Sponsors
Natural Remedies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy, male and/or female adult subjects age between 18 to 45 years old (both inclusive) 2.Subjects doing physical exercise regularly almost 5 days a week for the last two years. 3.Subjects within body mass index (BMI) range of 18.5–24.9 kg/m2. 4.Subjects with Systolic blood pressure (SBP) less than or equal to 130 mm Hg and diastolic blood pressure (DBP) less than or equal to 89 mm Hg. 5.Subjects Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit. 6. Subjects who can give written informed consent and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with known hypersensitivity to study product. 2.Subjects who have donated blood within one month before the study or have a blood hemoglobin level less than 12.0 g/dl. 3.Subjects with a history of any pulmonary disorder. 4.Known cases of hypertension and diabetes mellitus. 5. SpO2 less than 96% 6.Random blood glucose (RBG) levels greater than or equal to 140 mg/dl. 7.Abnormal thyroid stimulating hormone (TSH) value (less than 0.4 µIU/ml or more than 4.2µIU/ml). 8.Subject with a history of morbid obesity (BMI greater than 40%). 9.Subject with history of any medical condition where exercise is contraindicated. 10.Subjects who are unable to run due to any joint disorder. 11.History of smoking or active smokers using any form of tobacco. 12.Subjects who are currently on diuretics. 13.History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction. 14.Subjects having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder. 15.History of any significant neurological and psychiatric condition, which may affect the participation and inference of the study endpoints. 16.Participation in other clinical trials in the last 90 days before screening. 17.Subjects who are taking any nutritional supplements, medications, or steroids used to enhance physical performance. 18.History of any orthopedic injury or surgery that incapacitates the subject for exercise. 19.Any planned participation in any sporting event during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in cardiovascular endurance (VO2 max)Timepoint: Baseline to 56 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in lactic acid threshold.Timepoint: Baseline to 56 Days;2. Changes in blood creatine phosphokinase (CPK)Timepoint: Baseline to 56 Days;3. Change in subjective rate of perceived exertion.Timepoint: Baseline to 56 Days;4. Change in neuro muscular activation.Timepoint: Baseline to 56 Days;5. Changes in fatigue level.Timepoint: Baseline to 56 Days;6. Adverse eventsTimepoint: Baseline to 56 Days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed