ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	21 May 2018
Main ID:	ISRCTN18841175
Date of registration:	19/08/2009
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Effects of micronised purified flavonoic fraction on microcirculation in women suffering from chronic venous disease
Scientific title:	Effects of micronised purified flavonoic fraction on microcirculation in women suffering from chronic venous disease
Date of first enrolment:	22/07/2009
Target sample size:	240
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN18841175
Study type:	Interventional
Study design:	Single-centre double-blind randomised placebo-controlled parallel-group study (Treatment)
Phase:	Not Specified

Countries of recruitment
Brazil

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Eliete Bouskela
Address:	Instituto de Biologia Roberto Alcantara Gomes Dept Ciências Fisiologicasências Fisiologicas Rua Sao Francisco Xavier 524 - PHLC - Sala 104 - Lab. Presq em Microcirculaçao 20550-013 Rio de Janeiro Brazil
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Current inclusion criteria as of 29/11/2012:
1. Female suffering from primary chronic venous disease
2. Aged 18 to 30 years old

Previous inclusion criteria until 29/11/2012:
1. Female suffering from primary chronic venous disease
2. Aged 18 to 50 years old
Exclusion criteria: 1. Patients with irregular menstrual cycles
2. Women of childbearing potential without effective contraception

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Chronic venous disease
Circulatory System
Other disorders of veins

Intervention(s)

Micronised purified flavonoic fraction 500 mg over four menstrual cycles versus placebo.

Primary Outcome(s)

Effects on microcirculatory and biological parameters over four menstrual cycles

Secondary Outcome(s)

Safety

Secondary ID(s)

CL2-05682-099

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

Results available:	Yes
Date Posted:
Date Completed:	30/04/2012
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.