Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.

NCT ID: NCT04715126

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-09-02

Brief 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.

Conditions

Cardiovascular Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Oxyjun (Extract of Terminilia Arjuna).

Group Type: ACTIVE_COMPARATOR

Oxyjun

Intervention Type: OTHER

One capsule to be taken after breakfast with water.

Placebo (Microcrystalline cellulose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

One capsule to be taken after breakfast with water.

Interventions

Oxyjun

One capsule to be taken after breakfast with water.

Intervention Type: OTHER

Placebo

One capsule to be taken after breakfast with water.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Sanjay Wani, BAMS

Role: PRINCIPAL_INVESTIGATOR

Shop No.1,VardhmanApartment, Lokmanya Tilak Road,Dahisar west, Mumbai-400068.

Locations

Dr. Awate clinic

Mumbai, Maharashtra, India

Shree Polyclinic,

Mumbai, Maharashtra, India

Dr Rajesh Kewalramani Clinic

Mumbai, Maharashtra, India

Dr. Wani's Clinic

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

EB/200401/OXYJUN/AH

Identifier Type: -

Identifier Source: org_study_id