Effects of micronised purified flavonoic fraction on microcirculation in women suffering from chronic venous disease
| ISRCTN | ISRCTN18841175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18841175 |
| Protocol serial number | CL2-05682-099 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 20/07/2009
- Registration date
- 19/08/2009
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Instituto de Biologia Roberto Alcantara Gomes
Dept Ciências Fisiologicasências Fisiologicas
Rua Sao Francisco Xavier
524 - PHLC - Sala 104 - Lab. Presq em Microcirculaçao
Rio de Janeiro
20550-013
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre double-blind randomised placebo-controlled parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of micronised purified flavonoic fraction on microcirculation in women suffering from chronic venous disease |
| Study objectives | Clinical efficacy of micronised purified flavonoic fraction over four menstrual cycles. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Chronic venous disease |
| Intervention | Micronised purified flavonoic fraction 500 mg over four menstrual cycles versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Daflon® |
| Primary outcome measure(s) |
Effects on microcirculatory and biological parameters over four menstrual cycles |
| Key secondary outcome measure(s) |
Safety |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 240 |
| Key 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 |
| Key exclusion criteria | 1. Patients with irregular menstrual cycles 2. Women of childbearing potential without effective contraception |
| Date of first enrolment | 22/07/2009 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- Brazil
Study participating centre
20550-013
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.
29/11/2012: The target number of participants was updated from 180 to 240.
03/12/2010: The overall trial end date was updated from 30/06/2010 to 30/04/2012.
