Effects of resveratrol combined with calcium fructoborate (Fruitex B) in patients with stable angina pectoris

Completed

Conditions: Stable angina pectoris
Circulatory System
Angina pectoris

Registration Number: ISRCTN02337806

Lead Sponsor: atural Research, Ltd (Romania)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Male or female patients = 18 years
2. Diagnosis of angina pectoris (Class II-IV, Canadian Cardiology Society)
3. Informed consent obtained at selection

Exclusion Criteria

1. Unlikely to cooperate in the study
2. Legal incapacity or limited legal incapacity
3. Women who are pregnant, breast-feeding or women of childbearing potential
4. Participation in another drug or device trial at the same time or within the previous 30 days (or within 5 drug half-lives of the investigational drug, or within the time legally required by regulatory authorities, whichever are longer)
5. Known alcohol or drug abuse, known moderate or severe liver disease (Child-Pugh score > 7) or known severe renal disease (serum creatinine > 220 micromoles/L) or known anaemia (blood haemoglobin < 11 g/L)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ischemic cardiovascular events<br>2. The quality of life (Seattle Angina Questionnaire)<br>3. Serum High-Sensitivity C-Reactive Protein (hsCRP)<br>All outcomes will be assessed at baseline and at the end of the study period (2 months)

Secondary Outcome Measures

Name	Time	Method
1. Cardiac arrhythmias, assessed by standard transthoracic echocardiography (ECG)<br>2. Other cardiovascular markers<br>2.1. Sodium<br>2.2. Potassium<br>2.3. Creatinine<br>2.4. Alanine aminotransferase (ALT)<br>2.5. Aspartate aminotransferase (AST)<br>2.6. Fasting plasma glucose<br>2.7. Total cholesterol<br>2.8. Low Density Lipoprotein (LDL)-cholesterol <br>2.9. High Density Lipoprotein (HDL)-cholesterol <br>2.10. N-terminal prohormone brain natriuretic peptide (NT-proBNP)<br>All outcomes will be assessed at baseline and at the end of the study period (2 months)