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Not yet recruiting NCT07596979

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

No phase Interventional Coronary Artery Disease (CAD) Oxidative Stress Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ginger, Placebo.
Who it may be relevant to
Registry conditions: Coronary Artery Disease (CAD), Oxidative Stress, Inflammation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Dietary supplement Ginger
    Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
  • Dietary supplement Placebo
    The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.

Primary outcome measures

  • Change of inflammatory status in the participants [Time frame: Baseline and 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Health services research

Study locations

Brazil · 1 center
  • Denise mafra — Rio de Janeiro

Identifiers

NCT: NCT07596979 · Denise Mafra_DAC1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗