Clinical study to measure the effect of natural product in muscle pain and related swelling and stress in healthy subjects.
- Conditions
- Health Condition 1: M798- Other specified soft tissue disorders
- Registration Number
- CTRI/2022/06/043370
- Lead Sponsor
- AureaBiolabs Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change in muscle fatigue <br/ ><br>2) Change in endurance energy supply and recovery <br/ ><br>3) Change in neuro muscular activation <br/ ><br>4) Change in stress and anti-inflammatory biomarkers <br/ ><br>5) Change in BP and pulse <br/ ><br>6) Change in CBC and blood lipids <br/ ><br>7) Subjective pain score: Subjective pain rating will be inspected utilizing a <br/ ><br>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 Outcome Measures
Name Time Method Type and incidence of adverse events.Timepoint: 30 days.