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Effect of Propolis in patients with Angina

Effect of Green Propolis Extract (EPP-AF) in patients with Chronic Stable Angina. A randomized, blinded pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-876w38c
Enrollment
Unknown
Registered
2022-08-08
Start date
2021-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina pectoris

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Patients included in the study will be randomized (2:1) to use a propolis tablet (at a dose of 500mg/day) or an inert placebo. Ex

Sponsors

Hospital Ana Nery
Lead Sponsor
Hospital Ana Nery
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years; with stable coronary artery disease (CAD) symptomatic of angina despite optimized clinical treatment for at least four weeks with antianginal drugs (beta-blockers; calcium channel blockers; nitrates and/or trimetazidine)

Exclusion criteria

Exclusion criteria: Patients scheduled for surgical or percutaneous myocardial revascularization within the next 30 days; patients with obstruction of the left main coronary artery greater than 50%; patients who had acute coronary syndrome in the last two months; electrocardiogram at rest with left bundle branch block (LBBB), Wolff-Parkinson White (WPW), pacemaker rhythm, ST-segment depression more than 1mm, digitalis therapy; patients who have some physical limitation that make it impossible to perform the exercise test on a treadmill; heart failure with symptomatic reduced ejection fraction NYHA III-IV

Design outcomes

Primary

MeasureTime frame
It is expected that the use of propolis is related to an improvement in physical capacity (assessed by exercise stress test with improvement in exercise duration and improvement in metabolic equivalent of task - METS) after six weeks of treatment when compared to placebo

Secondary

MeasureTime frame
It is expected that the use of propolis will lead to a reduction in the absolute value of the ultrasensitive C-reactive protein (CRP), in the absolute value of the mean score on the Seattle Angina Questionnaire (QAS) in the angina domains (QAS-angina), in the total score obtained in all QAS domains at 30 days, number of angina episodes, angina graded in class III or IV after 30 days by the Canadian Cardiovascular Society (CCS), time to onset of angina during exercise on exercise stress test, and improvement in positive electrocardiographic criteria for ischemia (infra ST reduction in absolute number and presence of symptoms).

Countries

Brazil

Contacts

Public ContactClara Figueiredo

Hospital Ana Nery

clarasfigueiredo@gmail.com+557131171800

Outcome results

None listed

Source: REBEC (via WHO ICTRP)