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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OxyjunTM | Active Comparator | One capsule daily to be taken after breakfast for 56 days |
|
| Microcrystalline Cellulose | Placebo Comparator | One capsule daily to be taken after breakfast for 56 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxyjun TM | Dietary Supplement | One capsule daily to be taken after breakfast for 56 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF). | 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 | Screening |
| To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF). | 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 | Day 28 |
| To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF). | 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 | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac pumping capacity as evaluated by the ventricular stroke volume and cardiac output. | 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 |
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Inclusion Criteria:
Individuals of either sex, aged more than equal to 45 to less than equal to 70 years at the time of screening with BMI more than equal to 25 kg/metre square to less than equal to 34.9 kg/metre square.
Individuals with normal to high blood pressure (BP) [systolic BP more than equal to 120 mmHg and less than equal to 159 mmHg and/or diastolic BP more than equal to 80 mmHg and less than equal to 89 mmHg].
Individuals with waist circumference more than equal to 40 inches for men or 35 inches for women.
Individuals with normal to mildly deranged 'Left ventricular ejection' as per American College of Cardiology: LVEF more than equal to 45% and less than equal to 55%.
Fasting glucose level of more than equal to 110 mg/dL and less than equal to 160 mg/dL (without medication or with maximum 500 mg of daily dose of Metformin).
Individuals with Aspartate aminotransaminase (AST) and Alanine transaminase (ALT) within 2 times upper normal limit (ULN).
Individuals with 1.5 x Upper Normal Limit (ULN) of Creatinine.
Individuals having following values of haemoglobin:
Individuals with thyroid stimulating hormone (TSH) levels in between 0.27 IU/ml and 5 IU/ml both values included.
Individuals who demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
Willing to abstain from caffeine for 12 hours prior to the visit
Willing to abstain from alcohol and related products consumption for 48 hours prior to study visits
Must be literate, having the ability to understand, complete the study-based questionnaires, requirements and sign a written informed consent form, which must be completed prior to study specific requirements being performed.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sigma Hospital | Mumbai | Maharashtra | 400080 | India | ||
| Vedant Multispeciality Hospital |
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Randomized, Double Blind, Placebo-controlled, Parallel Group
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| Placebo |
| Dietary Supplement |
One capsule daily to be taken after breakfast for 56 days |
|
| Screening, Day 28 and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Responder to the product as assessed by the number of the participant having LVEF more than equal to 5 units increase. | Echocardiography define normal left ventricular ejection fraction (LVEF) as greater than 50% and greater than 55%, respectively. | Screening, Day 28 and Day 56 |
| To evaluate the effect of 8-week oral consumption of OxyjunTM on Work Productivity as assessed by the Work Productivity and Activity Impairment Questionnaire | 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. | Day 0, Day 28 and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Cardiac risk as assessed by the N-terminal pro b-type natriuretic peptide (NT-Pro BNP) | 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 | Day 0 and Day 56 |
| To evaluate the effect of 8-week oral consumption of Oxyjun TM on Physical activity as assessed by IPAQ-SF questionnaire | 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. | Day 0, day 28 and day 56 |
| Pune |
| Maharashtra |
| 411019 |
| India |
| Umarji Mother & Child Care Hospital | Pune | Maharashtra | 411045 | India |
| Swara Hospital | Thane | Maharashtra | 401303 | India |
| Silver Birch Multispecialty Hospital | Pune | Maharshtra | India |
| Upendra Medicare Hospital | Varanasi | Uttar Pradesh | 221001 | India |
| Janta hospital & Maternity Centre | Varanasi | Uttar Pradesh | 221011. | India |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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