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CompletedNCT04715126Updated Nov 17, 2021

Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.

An interventional study of Oxyjun and Placebo in Cardiovascular Health, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 4 sites in India. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-17.

Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

Terminalia arjuna, commonly known as arjuna, that belongs to the family of Combretaceae. Most clinical and experimental studies for Terminalia arjuna, have suggested that the crude drug possesses anti-ischemic, antioxidant, hypolipidemic, and antiatherogenic activities.

02

Conditions studied

  • Cardiovascular Health
03

In context

Lead sponsor

Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Participant of either sex, aged ≥ 30 to ≤ 70 years at the time of screening (completed). 2. Participants with normal to high normal blood pressure (BP) [systolic BP ≥ 120 and ≤ 139 mm Hg and/or diastolic BP ≥ 80 and ≤ 89 mm Hg] as defined by "The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH)". 3. Participants with normal to mildly deranged 'Left ventricular ejection' as per as per American College of Cardiology: LVEF ≥ 39 and ≤ 55%. 4. BMI ≥ 25 to ≤ 34.9 kg/m2 5. Normal level of Aspartate transaminase (AST) and Alanine transaminase (ALT) as specified by reference range of College of American Pathologists certified laboratory. 6. Normal level of Creatinine as specified by reference range of College of American Pathologists certified laboratory. 7. Participants must have demonstrated their willingness to participate in the study and comply with the study procedures and required visits. 8. Willing to abstain from caffeine, alcohol and related products consumption 12 hours prior to study visits. 9. Those having the ability to understand and sign a written informed consent form, which must be completed prior to study specific requirements being performed. 10. Must be literate and have the ability to complete the study-based questionnaires and requirements. 11. Female participants of childbearing age must be willing to use the accepted methods of contraception during the study.

Exclusion criteria

Exclusion Criteria:

  • Systolic BP ≥140 mm Hg and/ or Diastolic BP ≥ 90 mm Hg. 2. Fasting blood sugar ≥ 126 mg/dL 3. Presence of any unstable, acutely symptomatic, or life-limiting illness. 4. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (that might confound the interpretation of the study results), or put the participant at undue risk. 5. 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). 6. Chronic use of anti-inflammatory medications (≥ 5 tablets/20 days in last 3 months). 7. Individuals having a history of smoking or currently smoking and also using any form of smokeless tobacco. 8. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men. 9. Binge drinkers as defined by consumption of 4 or more alcohol containing beverages for women and 5 or more alcohol containing beverages for men within 2 hours. 10. Abnormal thyroid stimulating hormone (TSH) levels beyond the defined reference range (\<0.4 and > 4.0 IU/ml) 11. Participants unable to walk. 12. Participants with history of chronic caffeine use. 13. Participants 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. 14. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 15. Females undergoing hormone replacement treatments. 16. Menopausal females having less than 3 years of menopausal history 17. Those unwilling to abstain from other dietary supplements or medication (e.g. Hepatoprotective agents and other traditional medicines - Ayurveda, Siddhi, Chinese herbal medicine, Naturopathy). 18. Have participated in a study of an investigational product 90 days prior to the screening. 19. Participants with known or suspected hypersensitivity or intolerance to Investigational product. 20. Participants who are unable to comply with study requirements. 21. Any clinical signs or symptoms that in the opinion of investigator, can jeopardize the outcome of the study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Active comparator
    Oxyjun (Extract of Terminilia Arjuna).

    Other: Oxyjun

  • Placebo comparator
    Placebo (Microcrystalline cellulose)

    Other: Placebo

Interventions

  • OtherOxyjun

    One capsule to be taken after breakfast with water.

  • OtherPlacebo

    One capsule to be taken after breakfast with water.

06

What researchers measure

Primary outcomes

  1. Left ventricle ejection fraction

    1. To evaluate the effect of 8-week consumption of Oxyjun on cardiac pumping capacity of study participants as evaluated by Left ventricle ejection fraction (LVEF).

    Time frame: Day 0 to Day 56

Secondary outcomes

  1. Early filling (E) and the atrial phase (A) will be calculated at rest and the E/A ratio

    Reduction in myocardial stress of study participants as evaluated by decrease in E/A ratio at the end of week 8 (day 56) from baseline as compared to placebo.

    Time frame: Day 0 to Day 56

  2. Myocardial stress

    Decline in myocardial stress of study participants as assessed by decrease in rate pressure product at the end of week 8 (day 56) from baseline (day 0) as compared to placebo.

    Time frame: Day 0 to Day 56

  3. Fatigue severity scale

    Reduction in fatigue of study participants as assessed by decrease in Fatigue severity scale at week 4 (day 28), and week 8 (day 56) from baseline (day 0) as compared to placebo.

    Time frame: Day 0, Day 28, day 56

07

Study locations

4 sites
  • Dr. Awate clinic
    Mumbai, Maharashtra 400067, India
  • Shree Polyclinic,
    Mumbai, Maharashtra 400067, India
  • Dr Rajesh Kewalramani Clinic
    Mumbai, Maharashtra 400068, India
  • Dr. Wani's Clinic
    Mumbai, Maharashtra 400068, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04715126
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Jan 11, 2021
Primary completion
Sep 2, 2021
Completion
Sep 2, 2021
Last update
Nov 17, 2021

Study contacts

Dr. Sanjay Wani, BAMS
principal investigator · Shop No.1,VardhmanApartment, Lokmanya Tilak Road,Dahisar west, Mumbai-400068.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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