Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.

A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Health
• Intervention / Treatment: Other: Oxyjun; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxyjun (Extract of Terminilia Arjuna).	Other: Oxyjun; One capsule to be taken after breakfast with water.
Placebo Comparator: Placebo (Microcrystalline cellulose)	Other: Placebo; One capsule to be taken after breakfast with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 0 to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 to Day 56
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.	Day 0 to Day 56
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.	Day 0, Day 28, day 56

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Sanjay Wani, BAMS, Shop No.1,VardhmanApartment, Lokmanya Tilak Road,Dahisar west, Mumbai-400068.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): September 2, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EB/200401/OXYJUN/AH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No