Status:
COMPLETED
Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Collaborating Sponsors:
Enovate Biolife Pvt Ltd
Conditions:
Cardiac Function in Young Athletes
Eligibility:
MALE
18-40 years
Phase:
NA
Brief Summary
Young athletes are usually regarded as a special subgroup of healthy individuals with a unique lifestyle who are apparently invulnerable and often capable of extraordinary physical achievement. Most a...
Eligibility Criteria
Inclusion
- Male athletes aged 18 - 40 years having endurance exercise not less than 3-4 hrs. / week since at least last 12 weeks.
- Subject with left ventricular ejection fraction not less than 55% and not more than 70%.
- Subjects having body fat less than 16% as determined by skin fold assessment.
- Subject is willing to refrain from vigorous physical activity 12 hrs prior to clinic visit.
- Subject is a non-alcoholic/ non-smoker.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion
- Left Ventricular Ejection fraction less than 55 per cent by echocardiogram.
- Subjects suffering from anemia as defined by Hb levels ≤ 10 g/ dl.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥ 100 mm Hg) as defined by the average blood pressure measured at screening.
- History of coronary artery disease, myocardial infarction, hypertension or diabetes mellitus.
- History of cardiomyopathy, congenital heart defect, open heart surgery, or ongoing arrhythmia.
- Subjects having laboratory finding beyond specified normal limits at screening and in the opinion of the investigator possess significant threat for the study subject.
- Subject has a history or presence of clinically important renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- Use of any sleep aid medication within four days prior to each test day.
- Use of any psychotropic medication within four weeks of screening and throughout the study.
- Subject has a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit. Use of any other dietary supplements or herbal products.
- Recent history of (within 12 months of screening visit 1) or strong potential for alcohol or substance abuse.
- Subject has a known allergy or sensitivity to herbal product(s).
- Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02207101
Start Date
December 1 2014
End Date
July 1 2015
Last Update
July 10 2015
Active Locations (1)
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1
Suburban Diagnostics
Mumbai, Maharashtra, India, 400053