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

ISRCTN	ISRCTN02337806
DOI	https://doi.org/10.1186/ISRCTN02337806
Secondary identifying numbers	Research Project no.13/2010

Submission date: 21/03/2010
Registration date: 25/03/2010
Last edited: 25/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Romulus Scorei
Scientific

a.i.cuza no.19
Craiova
200385
Romania

Phone	+40 (0)251 41 59 60
Email	romulus_ion@yahoo.com

Study information

Study design	Randomised double blind active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Effects of resveratrol combined with calcium fructoborate (Fruitex B) in patients with stable angina pectoris. A 60 days double-blind-controlled pilot study
Study acronym	Res-FruitexB
Study objectives	The purpose of this study is to assess the short-term effects of Resveratrol combined with Calcium Fructoborate on the clinical and inflammatory status of patients presenting with stable angina pectoris. Resveratrol, a polyphenol phytoalexin, possesses diverse biochemical and physiological actions, including estrogenic, antiplatelet, and anti-inflammatory properties. Resveratrol has been shown to improve health and slow the progression of disease in various models. Several cardioprotective mechanisms have been identified including antioxidant, anti-inflammatory, and anti-fibrotic actions. Each of these actions is thought to have the ability to attenuate the pathophysiology underlying the cardiac structural remodelling which results from acute myocardial infarction. Both in acute and in chronic models, resveratrol attenuates myocardial ischemic reperfusion injury, atherosclerosis, and reduces ventricular arrhythmias. Boron compounds are known to show a variety of different biological activities. The soluble carbohydrate compounds of B buffer the reactive species of oxygen by developing organic peroxyborates. Boron exhibits inhibitory action on various enzymes, and particularly on prostaglandin endoperoxide synthases COX-1 and COX-2. It is more ethically justified to use active components in each group. Therefore this is a comparative study rather than placebo-controlled study. Besides, it may show synergy between FrxB and Resveratrol.
Ethics approval(s)	Institutional Ethics Committee of the Cardiology Center of University of Medicine and Pharmacy of Craiova, Romania, approved in February 2010 (ref: 400/2010) The trial is also in compliance with the Helsinki Declaration of 1975 as revised in 1983
Health condition(s) or problem(s) studied	Stable angina pectoris
Intervention	The study was double-blind and controlled. Patients will be randomised to the following groups 1. Combination of FrxB (120mg) with Resveratrol (10mg) 2. FrxB only 3. Resveratrol only Study drugs will be taken orally and daily over 60 days. There will be no follow up beyond the end of the intervention.
Intervention type	Other
Primary outcome measure	1. Ischemic cardiovascular events 2. The quality of life (Seattle Angina Questionnaire) 3. Serum High-Sensitivity C-Reactive Protein (hsCRP) All outcomes will be assessed at baseline and at the end of the study period (2 months)
Secondary outcome measures	1. Cardiac arrhythmias, assessed by standard transthoracic echocardiography (ECG) 2. Other cardiovascular markers 2.1. Sodium 2.2. Potassium 2.3. Creatinine 2.4. Alanine aminotransferase (ALT) 2.5. Aspartate aminotransferase (AST) 2.6. Fasting plasma glucose 2.7. Total cholesterol 2.8. Low Density Lipoprotein (LDL)-cholesterol 2.9. High Density Lipoprotein (HDL)-cholesterol 2.10. N-terminal prohormone brain natriuretic peptide (NT-proBNP) All outcomes will be assessed at baseline and at the end of the study period (2 months)
Overall study start date	30/03/2010
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100 patients
Key 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
Key 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)
Date of first enrolment	30/03/2010
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

Romania

Study participating centre

a.i.cuza no.19

Craiova
200385
Romania

Sponsor information

Natural Research, Ltd (Romania)
Industry

ai cuza no.19
Craiova
200385
Romania

Phone	+40 (0)251 41 59 60
Email	romulus_ion@yahoo.com
Website	http://www.naturalresearch.ro

Funders

Funder type

Industry

Natural Research, Ltd (Romania) - Research Project (ref: 13/2010)

No information available

Cardiology Centre of University of Medicine and Pharmacy of Craiova (Romania)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan