Clinical study to measure the effect of natural product in muscle pain and related swelling and stress in healthy subjects.

Completed

• Conditions: Other specified soft tissue disorders,

• Registration Number: CTRI/2022/06/043370
• Lead Sponsor: AureaBiolabs Private Limited

Brief Summary

This clinicalstudy will be conducted to measure the effect of natural phytochemicalformulation on the muscle fatigue, endurance energy supply, recovery and neuromuscular activation in delayed muscle soreness (DOMS),and related inflammation and stress in healthy subjects. Total 110 subjectswill be enrolled in the study.

All the subjectswill be screened based on inclusion and exclusion criteria. Subjects whofulfilled the requirement will enrolled in the study. All the subjects will befollowed up for day 4, 15, 30 and 60.The vitals and physical examination willbe recorded during screening and also during all the visits in entire study.During randomization, performance of eccentric exercise, assessment of subjectivepainrating (NPRS), assessment of muscle fatigue with fatigue index will bemeasured. On respective visit, change in muscle fatigue, change in enduranceenergy supply and recovery, change in neuro muscular activation, change instress and anti-inflammatory biomarkers, change in BP and pulse, change in CBCand blood lipids and measuring subjective pain score.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-07
• Study Completion: 2022-12-10
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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

• 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.
• 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 subject’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	30 days.
4) Change in stress and anti-inflammatory biomarkers	30 days.
2) Change in endurance energy supply and recovery	30 days.
3) Change in neuro muscular activation	30 days.
6) Change in CBC and blood lipids	30 days.
5) Change in BP and pulse	30 days.
7) Subjective pain score: Subjective pain rating will be inspected utilizing a	30 days.
numericalpain intensity scale. The visual assessment score (VAS) scale ranged from 0 (no pain at all) to 10 (extremely intense pain)	30 days.

Secondary Outcome Measures

Name	Time	Method
Type and incidence of adverse events.	30 days.

Trial Locations

Locations (2)

Navneet memorial Hospital “Sushrushaâ€; 🇮🇳 Ahmadabad, GUJARAT, India

Parikh Hospitals; 🇮🇳 Ahmadabad, GUJARAT, India

Navneet memorial Hospital “Sushrushaâ€

🇮🇳Ahmadabad, GUJARAT, India

Dr Vaishal Sheth

Principal investigator

9925965133

drvaishalsheth@gmail.com