Cardiac Function in Young AthletesEnduoxyNCT02207101
Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury
A study testing E-OJ-01 (OXYJUN) in people with Cardiac Function in Young Athletes, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial 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 athletic disciplines to some extent combine endurance and strength modes of physical conditioning. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function in Young Athletes
- What is being tested?
- E-OJ-01 (OXYJUN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2014to Jul 2015
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Investigational Product E-OJ-01 (OXYJUN) on Left Ventricular Ejection Fraction and Markers of Cardiovascular Injury.
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 athletic disciplines to some extent combine endurance and strength modes of physical conditioning. Acute responses to endurance exercise training include substantial increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood pressure in-spite of this, high intensity chronic training such as marathons, very long distance bicycle racing etc., can lead to transient acute volume overload of the atria and right ventricle, with transient reductions in right ventricular ejection fraction and elevations of cardiac biomarkers. Although these biomarkers generally normalize back within seven to ten days, these transient changes may sooner or later mark the beginning of processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .
Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been no new advancements in finding an alternate option which can protect the cardio vascular system in the athletes.
Read more
Hence in order to address the need of the hour and also to avoid the cardio vascular risk in athletes along with improvising the endurance capacity, Enovate Biolife is in the process of development of an innovative product "E-OJ-01".
E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes by enhancing ejection fraction which in turn improves cardiac output. This finally is hypothysed to increase the maximal oxygen uptake capacity in athletes.
- Conditions
- Cardiac Function in Young Athletes
- Being tested
- E-OJ-01 (OXYJUN), Placebo
- Keywords
- Young athletes, Cardiac endurance, Herbal, Ejection Fraction, Basic Research, Cardiovascular Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-OJ-01 (OXYJUN)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| E-OJ-01 (OXYJUN) | Active comparator | E-OJ-01 (OXYJUN). Dose: 01 capsule to be taken orally daily after lunch. Receives: Dietary Supplement: E-OJ-01 (OXYJUN) |
| Placebo | Placebo comparator | Matching placebo capsules [for E-OJ-01 (OXYJUN)] composed of microcrystalline cellulose. Dose: 01 capsule to be taken orally daily after lunch. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction
Measured: Day 0, Day 28 and Day 56
Secondary outcomes (1)
Change in Serum Troponin-T
Measured: Day 0 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 posted1 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Function in Young AthletesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Enovate Biolife Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- Ravi Chavan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207101
- Sponsor's protocol ID
- EB/141005/OXY-2/CE
- Acronym
- Enduoxy
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2014
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Girandola RN, Srivastava S. Effect of E-OJ-01 on Cardiac Conditioning in Young Exercising Adults: A Randomized Controlled Trial. Am J Ther. 2017 May;24(3):e298-e307. doi: 10.1097/MJT.0000000000000542.
PubMed 27930383
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Investigational Product E-OJ-01 (OXYJUN) on Left Ventricular Ejection Fraction and Markers of Cardiovascular Injury.
- ClinicalTrials.gov ID
- NCT02207101
- Acronym / sponsor ID
- Enduoxy / EB/141005/OXY-2/CE
- Conditions
- Cardiac Function in Young Athletes
- Keywords
- Young athletes, Cardiac endurance, Herbal, Ejection Fraction, Basic Research, Cardiovascular Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Enovate Biolife Pvt Ltd
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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.
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 athletic disciplines to some extent combine endurance and strength modes of physical conditioning. Acute responses to endurance exercise training include substantial increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood pressure in-spite of this, high intensity chronic training such as marathons, very long distance bicycle racing etc., can lead to transient acute volume overload of the atria and right ventricle, with transient reductions in right ventricular ejection fraction and elevations of cardiac biomarkers. Although these biomarkers generally normalize back within seven to ten days, these transient changes may sooner or later mark the beginning of processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .
Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been no new advancements in finding an alternate option which can protect the cardio vascular system in the athletes.
Hence in order to address the need of the hour and also to avoid the cardio vascular risk in athletes along with improvising the endurance capacity, Enovate Biolife is in the process of development of an innovative product "E-OJ-01".
E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes by enhancing ejection fraction which in turn improves cardiac output. This finally is hypothysed to increase the maximal oxygen uptake capacity in athletes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-OJ-01 (OXYJUN) | Active comparator | Dietary Supplement: E-OJ-01 (OXYJUN)E-OJ-01 (OXYJUN). Dose: 01 capsule to be taken orally daily after lunch. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching placebo capsules [for E-OJ-01 (OXYJUN)] composed of microcrystalline cellulose. Dose: 01 capsule to be taken orally daily after lunch. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| E-OJ-01 (OXYJUN) | Dietary supplement | E-OJ-01 (OXYJUN) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in Left Ventricular Ejection Fraction
Time frame: Day 0, Day 28 and Day 56
1 secondary outcome
Change in Serum Troponin-T
Time frame: Day 0 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 10 Jul 2015.
- Derived from this study: PubMed 27930383Girandola RN, Srivastava S. Effect of E-OJ-01 on Cardiac Conditioning in Young Exercising Adults: A Randomized Controlled Trial. Am J Ther. 2017 May;24(3):e298-e307. doi: 10.1097/MJT.0000000000000542.
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.
Ravi Chavan, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-OJ-01 (OXYJUN) in people with Cardiac Function in Young Athletes, 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 6 inclusion and 14 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 10 Jul 2015. 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 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?
Change in Left Ventricular Ejection Fraction (time frame: Day 0, Day 28 and Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207101, which also lists 1 linked publication.
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 10 Jul 2015.