Ginger in the Modulation of Inflammatory Cytokines and Oxidative Stress in Patients With Coronary Artery Disease
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2026
CompletedStudy Start
First participant enrolled
May 18, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 19, 2026
May 1, 2026
1.5 years
May 12, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of inflammatory status in the participants
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
Study Arms (2)
Ginger Group
EXPERIMENTALParticipants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
Placebo Group
PLACEBO COMPARATORThe placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.
Interventions
Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denise mafra
Rio de Janeiro, 24220-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludmila cardozo
Universidade Federal Fluminense
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2026
First Posted
May 19, 2026
Study Start
May 18, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Participant data will not be public to other research unless necessary.