Metabolic DisorderNCT06496880
A Study to Evaluate the Efficacy of OxyjunTM on Cardiac Pumping Capacity as Well as Work Productivity in Individuals With Metabolic Risk.
A study testing Oxyjun TM in people with Metabolic Disorder, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorder
- What is being tested?
- Oxyjun TM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 7 sitesIndia
- Study dates
- 10 Sep 2024to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- Individuals with 1.5 x Upper Normal Limit (ULN) of Creatinine.
- Individuals having following values of haemoglobin:
- Female - more than equal to 11 mg/dl
- Male - more than equal to 12 mg/dl
- 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.
Who cannot join
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgement of the investigator, would interfere with the individuals ability to provide informed consent, comply with the study protocol, or put the individual at undue risk.
- Using Omega fish oil supplements, anticonvulsants, Coenzyme Q10, Vitamin K2, proton pump inhibitors, loop diuretics, anticoagulants, barbiturates, anti-epileptic medications and any herbal supplements (e.g. flax seeds, chia seeds).
- Chronic use of anti-inflammatory medications (more than equal to 5 tablets/20 days in last 3 months).
- Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
- High-risk drinking as defined by consumption of 4 or more drinks of alcohol containing beverages on any day or 10 or more drinks of alcohol containing beverages per week for women and 5 or more drinks of alcohol containing beverages on any day or 14 or more drinks of alcohol containing beverages per week for men.
- Individuals unable to walk. Individuals with a history of chronic caffeine use with more than 3 cups of caffeinated beverage/ day.
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- Individuals who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put him/her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Females undergoing hormone replacement treatments.
- Peri- or post-menopausal females having less than equal to 1 year of irregular or complete absence of menstrual cycle.
- Those unwilling to abstain from other dietary supplements or medication (e.g. Hepatoprotective agents and complementary and alternative medicine).
- Have participated in a study of an investigational product 90 days prior to the screening.
- Individuals with known or suspected hypersensitivity or intolerance to Investigational product.
- Individuals who are unable to comply with study requirements.
- Individuals with a history of autoimmune disorders
- Individuals with a history of immunocompromised status
- Any clinical signs or symptoms that in the opinion of the investigator can jeopardize the outcome of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Sigma Hospital
Mumbai, Maharashtra, 400080
Vedant Multispeciality Hospital
Pune, Maharashtra, 411019
Umarji Mother & Child Care Hospital
Pune, Maharashtra, 411045
Silver Birch Multispecialty Hospital
Pune, Maharshtra
Swara Hospital
Thane, Maharashtra, 401303
Upendra Medicare Hospital
Varanasi, Uttar Pradesh, 221001
Janta hospital & Maternity Centre
Varanasi, Uttar Pradesh, 221011.
About this study
Official title: 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
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.
- Conditions
- Metabolic Disorder
- Being tested
- Oxyjun TM, Placebo
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxyjun TMDietary supplement
One capsule daily to be taken after breakfast for 56 days
PlaceboDietary supplement
One capsule daily to be taken after breakfast for 56 days
| Study group | Role | What they receive |
|---|---|---|
| OxyjunTM | Active comparator | One capsule daily to be taken after breakfast for 56 days Receives: Dietary Supplement: Oxyjun TM |
| Microcrystalline Cellulose | Placebo comparator | One capsule daily to be taken after breakfast for 56 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 56
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 0, day 28 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Sep 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double Blind, Placebo-controlled, Parallel Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496880
- Sponsor's protocol ID
- EB/240301/OXY/CPC
- Status last verified
- Jun 2025
- First submitted
- 3 Jul 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06496880
- Acronym / sponsor ID
- EB/240301/OXY/CPC
- Conditions
- Metabolic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Placebo-controlled, Parallel Group
| Arm | Type | Receives |
|---|---|---|
| OxyjunTM | Active comparator | Dietary Supplement: Oxyjun TMOne capsule daily to be taken after breakfast for 56 days |
| Microcrystalline Cellulose | Placebo comparator | Dietary Supplement: PlaceboOne capsule daily to be taken after breakfast for 56 days |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (17 listed)
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgement of the investigator, would interfere with the individuals ability to provide informed consent, comply with the study protocol, or put the individual at undue risk.
- Using Omega fish oil supplements, anticonvulsants, Coenzyme Q10, Vitamin K2, proton pump inhibitors, loop diuretics, anticoagulants, barbiturates, anti-epileptic medications and any herbal supplements (e.g. flax seeds, chia seeds).
- Chronic use of anti-inflammatory medications (more than equal to 5 tablets/20 days in last 3 months).
- Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
- High-risk drinking as defined by consumption of 4 or more drinks of alcohol containing beverages on any day or 10 or more drinks of alcohol containing beverages per week for women and 5 or more drinks of alcohol containing beverages on any day or 14 or more drinks of alcohol containing beverages per week for men.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxyjun TMOne capsule daily to be taken after breakfast for 56 days | Dietary supplement | OxyjunTM |
| PlaceboOne capsule daily to be taken after breakfast for 56 days | Dietary supplement | Microcrystalline Cellulose |
Primary outcome
To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
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
To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
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
To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF).
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
5 secondary outcomes
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Day 0, day 28 and day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxyjun TM in people with Metabolic Disorder, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of 8-week oral consumption of OxyjunTM on left ventricular function as evaluated by Left ventricle ejection fraction (LVEF). (time frame: Screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.