Ginger in the Modulation of Inflammatory Cytokines and Oxidative Stress in Patients With Coronary Artery Disease

Universidade Federal Fluminense

Status: Not yet enrolling

Conditions: Inflammation; Oxidative Stress; Coronary Artery Disease (CAD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ginger

Study type: Interventional

Funder types: Other

Identifiers

NCT07596979

Denise Mafra_DAC1

Details and patient eligibility

About

The study aims to evaluate the effect of ginger supplementation on inflammatory cytokines and markers of oxidative stress in patients with Coronary Artery Disease (CAD). A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.

Full description

Ginger (Zingiber officinale Roscoe) contains phenolic compounds, such as gingerols, shogaols, and zingiberene, recognized for their antioxidant and anti-inflammatory properties, and may act as an adjuvant strategy in the prevention and management of CAD. However, there are no studies in CAD patients evaluating these data.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both sexes
• Over 18 years of age;
• Diagnosed with Coronary Artery Disease: confirmed by coronary angiography, coronary computed tomography angiography, or functional testing with ischemic load);
• Participants who are asymptomatic or have angina limited to functional class III will be considered;
• Patients who have already undergone coronary revascularization and angioplasty may participate;
• the last acute coronary event must have occurred more than one year ago.

Exclusion criteria

• Unstable Coronary Artery Disease;
• Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
• Unstable angina;
• NYHA functional class III or higher;
• Advanced chronic kidney disease (creatinine clearance < 30 ml/min/1.73 m²);
• Individuals with autoimmune diseases.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Ginger Group

Experimental group

Description:

Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.

Treatment:

Dietary Supplement: Ginger

Placebo Group

Placebo Comparator group

Description:

The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.

Treatment:

Dietary Supplement: Placebo