Health Condition 1: M798- Other specified soft tissue disorders
Conditions
Interventions
Intervention1: Rephyll-(Natural Phytochemical Formulation): Single oral 500 mg dosage in capsule form, daily morning for 30 days after breakfast.
Control Intervention1: Placebo: Single oral 500 mg dos
Sponsors
AureaBiolabs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject has provided written, signed and dated informed consent to participate in the study. 2) Subject is willing and able to comply with the protocol, 3) Male or female subjects between 19-50 years of age (both inclusive). 4) Subjects should be untrained as defined by, less active that is regular exercise for less than 4 h per week. 5) Subject is in good health as determined by a health history and as per Investigator discretion. 6) Subject is untrained in resistance/power exercise.
Exclusion criteria
Exclusion criteria: 1) Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. 2) Subject has a history of alcohol or other drug abuse in the past year. 3) Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 4) Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. 5) Subject has a known allergy or sensitivity to any ingredient in the test product. 6) Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 7) Subject has a history of difficulty swallowing large pills or tablets. 8) Subject has used creatine within 9 weeks prior to screening. 9) Subject has a history of orthopedic injury or surgery within the last year. 10) Subject has any physical condition considered a contraindication to the type of exercise performed in the study. 11) Subject has had an abnormal resting ECG. 12) Investigator is uncertain about subjectâ??s capability or willingsness to comply with the protocol requirments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in muscle fatigue 2) Change in endurance energy supply and recovery 3) Change in neuro muscular activation 4) Change in stress and anti-inflammatory biomarkers 5) Change in BP and pulse 6) Change in CBC and blood lipids 7) Subjective pain score: Subjective pain rating will be inspected utilizing a numericalpain intensity scale. The visual assessment score (VAS) scale ranged from 0 (no pain at all) to 10 (extremely intense pain)Timepoint: 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Type and incidence of adverse events.Timepoint: 30 days. | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed