Oxyjun TM
Dietary SupplementOne capsule daily to be taken after breakfast for 56 days
NCT Number: NCT06496880
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy of OxyjunTM on Cardiac Pumping Capacity as well as Work Productivity in Individuals with Metabolic Risk.
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Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Sigma Hospital, Mumbai, Maharashtra, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One capsule daily to be taken after breakfast for 56 days
One capsule daily to be taken after breakfast for 56 days
Time frame: Screening
LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.
LVEF is calculated using the formula- LVEF: [SV/EDV] x 100
Time frame: Day 28
LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.
LVEF is calculated using the formula- LVEF: [SV/EDV] x 100
Time frame: Day 56
LVEF is the fraction of chamber volume ejected during systole (stroke volume or SV) in relation to the volume of blood in the ventricle at the end of diastole (end-diastolic volume or EDV). The LVEF will be assessed by using M-mode 2D Echo.
LVEF is calculated using the formula- LVEF: [SV/EDV] x 100
Time frame: Screening, Day 28 and Day 56
Cardiac output is determined by multiplying heart rate and stroke volume and is typically measured in liters per minute cardiac output is expressed as CO = HR × SV.
The normal range for stroke volume is typically 55-100 mL. An average resting heart rate is approximately 75 beats per minute (bpm), but it can vary between 60-100 bpm in some individuals.
The normal cardiac output falls within the range of 4.0-6.0 L/min at rest
Time frame: Screening, Day 28 and Day 56
Echocardiography define normal left ventricular ejection fraction (LVEF) as greater than 50% and greater than 55%, respectively.
Time frame: Day 0, Day 28 and Day 56
The Work Productivity and Activity Impairment (WPAI) questionnaire stands as a thoroughly validated tool designed to assess impairments in both work-related tasks and general activities.
In this study, a 10 point Visual Analogue scale is used to evaluate how health problems affect the participant's ability to do their regular activity where 0 means no effect and 10 means complete hinderance in daily activities.
Time frame: Day 0 and Day 56
NT-Pro BNP levels have been noted in various cardiovascular conditions, encompassing chronic heart failure and left ventricular dysfunction.
Normal reference range considered in this study for males and females for NT-Pro BNP is <125 pg/ml
Time frame: Day 0, day 28 and day 56
The IPAQ-SF is a standardized and culturally adaptable tool to assess habitual physical activity in individuals across the globe.
Scoring a HIGH level of physical activity on the IPAQ-SF means the physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
Scoring a MODERATE level of physical activity on the IPAQ-SF means one is doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.
Scoring a LOW level of physical activity on the IPAQ-SF means that the participant is not meeting any of the criteria for either MODERATE or HIGH levels of physical activity.
Vedic Lifesciences Pvt. Ltd.
Industry
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy of OxyjunTM on Cardiac Pumping Capacity as Well as Work Productivity in Individuals With Metabolic Risk
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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