Pelvic Congestion SyndromeNCT04512443
Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome
An observational study of Pelvic Congestion Syndrome, run by Interregional Clinical Diagnostic Center, Russia at 2 sites in Russia.
Trial summary
The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome . Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pelvic Congestion Syndrome
- What is being tested?
- Daflon
- How many people
- 83 participants
- Where
- 2 sitesRussia
- Study dates
- 28 Dec 2019to 28 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: women with Pelvic congestion syndrome
Who may be able to join
- •The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning
Who cannot join
- Severe disease of the gastrointestinal tract or hematopoietic system
- Terminal stage of cardiovascular, respiratory, renal or hepatic failure
- Grade IV malignancy
- Peripheral artery disease (PAD) of the lower extremities, any type of diabetes, or mental disease.
- Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
Trial locations and contacts
2 sites in 1 country.
About this study
The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome .
- Conditions
- Pelvic Congestion Syndrome
- Being tested
- Daflon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaflonDrug
All consecutive patients were randomly allocated into 2 groups to receive Daflon (Detralex) at a dose of 1000 mg once daily (study group) or placebo (control group).
| Study group | Role | What they receive |
|---|---|---|
| 1 | 42 women (treated with Daflon 1000 mg (study group)) Receives: Drug: Daflon | |
| 2 | 41 women (placebo (control group)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Varicose Veins Questionnaire
Assessment of quality of life according to the questionnaire before and after treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start28 Dec 2019
- Primary completion28 Mar 2020
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interregional Clinical Diagnostic Center, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akhmetzianov Rustem, Interregional Clinical Diagnostic Center, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512443
- Sponsor's protocol ID
- Daflon25122019
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT04512443
- Acronym / sponsor ID
- Daflon25122019
- Conditions
- Pelvic Congestion Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Interregional Clinical Diagnostic Center, RussiaUniversity, hospital or other
- Study start
- 28 Dec 2019 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Daflon42 women (treated with Daflon 1000 mg (study group)) |
| 2 | – | –41 women (placebo (control group)) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with Pelvic congestion syndrome
Key inclusion criteria (1 listed)
- •The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning
Key exclusion criteria (5 listed)
- Severe disease of the gastrointestinal tract or hematopoietic system
- Terminal stage of cardiovascular, respiratory, renal or hepatic failure
- Grade IV malignancy
- Peripheral artery disease (PAD) of the lower extremities, any type of diabetes, or mental disease.
- Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaflonAll consecutive patients were randomly allocated into 2 groups to receive Daflon (Detralex) at a dose of 1000 mg once daily (study group) or placebo (control group). | Drug | 1 |
Primary outcome
Pelvic Varicose Veins Questionnaire
Time frame: 2 months
Assessment of quality of life according to the questionnaire before and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Congestion Syndrome, run by Interregional Clinical Diagnostic Center, Russia at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Varicose Veins Questionnaire (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.