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

May 12, 2026 updated by: Universidade Federal Fluminense
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ginger Group
Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
Dietary supplement: Ginger
Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
Other Names:
  • ginger extract
Placebo Comparator: Placebo Group
The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.
Dietary supplement: Placebo
The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of inflammatory status in the participants
Time Frame: Baseline and 8 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Ludmila cardozo, Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Denise Mafra_DAC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will not be public to other research unless necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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