Effect of Propolis in patients with Angina

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: D05.750.078.840.762 This is a two‐arm, double‐blind, randomized controlled clinical trial. Patients included in the study will be randomized (1:1) to use a propolis tablet (at a dose of 500mg/day) or an inert placebo. Experimental group: 30 individuals with coronary artery disease complaining of angina. Control group: 30 individuals with coronary artery disease complaining of angina. Randomization is performed randomly after matching some clinical characteristics by the main researcher, such as: age, presence of comorbidities, classification of angina. The information on which group the patient was allocated is given to the responsible pharmacist who delivers the placebo or propolis, and the packages are identical. Thus, the research physician and the patient are blinded. Patients must use propolis/placebo for a period of si Xweeks, after which they are reassessed by the researcher. The prescription is one (01) tablet twice a day for si Xweeks. CONDITION: Angina pectoris PRIMARY OUTCOME: 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 OUTCOME: 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). 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)
Epistemonikos ID: 79d1ca1e0ac94cd07f6e1782180ddf3b84a9cd7c
First added on: Aug 26, 2024