A clinical study to evaluate the efficacy of herbal sports nutrition for physical endurance in healthy volunteers.

Not Applicable

Completed

• Registration Number: CTRI/2018/01/011612
• Lead Sponsor: Aurea Biolabs Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-07-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1 Male healthy adult subjects ranging in age from 18 to 55 years (both inclusive)

normotensive, physically active but not exercise trained.

2 Willingness to follow the protocol requirements as evidenced by written, informed

consent.

3 Agree not to use any medication including vitamins and minerals, during or before

the course of this study.

4 Subjects whose blood chemistries are within a normal range or not considered

clinically significant if outside the normal range.

5 Non smokers and non-alcoholics.

6 Willing to come for all follow-up visits

Exclusion Criteria

Any clinically significant medical history, medical finding or an ongoing medical or

psychiatric condition exists which in the opinion of the Investigator could

jeopardize the safety of the subject, impact validity of the study results or interfere

with the completion of study according to the protocol

Significant abnormal findings as determined by baseline history, physical

examination, vital signs (blood pressure, pulse rate, respiration rate, temperature)

hematology, serum chemistry.

History of hypersensitivity reactions.

Smokers and alcoholics

History of migraine, asthma

Participation in a clinical study during the preceding 90 days.

Evidence of ischemic heart disease by history or abnormal resting or exercise

electrocardiogram (ECG) ( > 1mm ST segment depression), regional wall motion

abnormalities, left ventricular systolic dysfunction or significant valvular disease.

Blood or blood products donated in past 30 days prior to study supplement

administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified