Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome

August 12, 2020 updated by: Akhmetzianov Rustem, Interregional Clinical Diagnostic Center, Russia
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kazan, Russian Federation, 420097
        • Akhmetzianov Rustem
      • Kazan, Russian Federation
        • Roman Bredikhin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with Pelvic congestion syndrome

Description

Inclusion Criteria:

•The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
42 women (treated with Daflon 1000 mg (study group))
Drug: Daflon
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).
2
41 women (placebo (control group))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Varicose Veins Questionnaire
Time Frame: 2 months
Assessment of quality of life according to the questionnaire before and after treatment
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Interregional Clinical Diagnostic Center, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2019

Primary Completion (Actual)

March 28, 2020

Study Completion (Actual)

March 28, 2020

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Daflon25122019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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