HealthyNCT03854786
Aerobic Fitness in Overweight and Obese Individuals
A study testing Oxyjun and Pacebo in people with Healthy, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxyjun and Pacebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteIndia
- Study dates
- 3 Jan 2020to 28 May 2020
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index ≥ 25 - ≤ 34.9 kg/m2.
- Waist Circumference ≥ 80 cms.
- Non-smoker.
- BP ≤ 140/90 mm Hg
- FBS ≤ 125 mg/dl
- Hb ≥ 11 g/ dl
- Can abstain from strenuous exercise and alcohol for at least 48 hours.
- Can abstain from caffeine for at least 24 hours.
Who cannot join
- Participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc).
- Inter-arm blood pressure is ≥10 mm Hg.
- Known cases of type II Diabetes Mellitus.
- Known cases of hypertension with or without anti-hypertensive medication.
- Visual or balance problems, or who cannot walk on a treadmill without using the handrails.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.
Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness.
Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.
- Conditions
- Healthy
- Being tested
- Oxyjun, Pacebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyjunDietary supplement
Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
PaceboDietary supplement
Methyl Crystalline Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Oxyjun | Active comparator | Oxyjun- 400 mg OD after breakfast Receives: Dietary Supplement: Oxyjun |
| Methyl Crystalline Cellulose | Placebo comparator | Methyl Crystalline Cellulose- 400 mg OD after breakfast Receives: Dietary Supplement: Pacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
Measured by change in VO2 max
Measured: From baseline to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start3 Jan 2020
- Primary completion5 Mar 2020
- Study completion28 May 2020
Why it stopped: Due to Covid - 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 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
- NCT03854786
- Sponsor's protocol ID
- EB/181201/OXYJUN/EVRG
- Status last verified
- Jan 2020
- First submitted
- 21 Feb 2019
- Last updated
- 19 Jan 2021
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.
- ClinicalTrials.gov ID
- NCT03854786
- Acronym / sponsor ID
- EB/181201/OXYJUN/EVRG
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid - 19 pandemic
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 26 Feb 2019 (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.
Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness.
Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxyjun | Active comparator | Dietary Supplement: OxyjunOxyjun- 400 mg OD after breakfast |
| Methyl Crystalline Cellulose | Placebo comparator | Dietary Supplement: PaceboMethyl Crystalline Cellulose- 400 mg OD after breakfast |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body Mass Index ≥ 25 - ≤ 34.9 kg/m2.
- Waist Circumference ≥ 80 cms.
- Non-smoker.
- BP ≤ 140/90 mm Hg
- FBS ≤ 125 mg/dl
Key exclusion criteria (5 listed)
- Participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc).
- Inter-arm blood pressure is ≥10 mm Hg.
- Known cases of type II Diabetes Mellitus.
- Known cases of hypertension with or without anti-hypertensive medication.
- Visual or balance problems, or who cannot walk on a treadmill without using the handrails.
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 |
|---|---|---|
| OxyjunOxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna. | Dietary supplement | Oxyjun |
| PaceboMethyl Crystalline Cellulose | Dietary supplement | Methyl Crystalline Cellulose |
Primary outcome
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
Time frame: From baseline to Day 56
Measured by change in VO2 max
Results and safety
The study was stopped early (reason given: Due to Covid - 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxyjun and Pacebo in people with Healthy, run by Vedic Lifesciences Pvt. Ltd. at 1 site 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Due to Covid - 19 pandemic). Results are not available in the source record.
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 investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals (time frame: From baseline to Day 56). 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 19 Jan 2021.