Condition category
Circulatory System
Date applied
21/03/2010
Date assigned
25/03/2010
Last edited
25/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Romulus Scorei

ORCID ID

Contact details

a.i.cuza no.19
Craiova
200385
Romania
+40 (0)251 41 59 60
romulus_ion@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Research Project no.13/2010

Study information

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

Acronym

Res-FruitexB

Study hypothesis

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

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

Study design

Randomised double blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

30/03/2010

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients

Participant 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)

Recruitment start date

30/03/2010

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Romania

Trial participating centre

a.i.cuza no.19
Craiova
200385
Romania

Sponsor information

Organisation

Natural Research, Ltd (Romania)

Sponsor details

ai cuza no.19
Craiova
200385
Romania
+40 (0)251 41 59 60
romulus_ion@yahoo.com

Sponsor type

Industry

Website

http://www.naturalresearch.ro

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes