NCT04512443

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 10, 2020

Last Update Submit

August 12, 2020

Conditions

Pelvic Congestion Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pelvic Varicose Veins Questionnaire

    Assessment of quality of life according to the questionnaire before and after treatment

    2 months

Study Arms (2)

1

42 women (treated with Daflon 1000 mg (study group))

Drug: Daflon

2

41 women (placebo (control group))

Interventions

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).

1

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women with Pelvic congestion syndrome

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akhmetzianov Rustem

Kazan', 420097, Russia

Location

Roman Bredikhin

Kazan', Russia

Location

MeSH Terms

Interventions

Diosmin

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 13, 2020

Study Start

December 28, 2019

Primary Completion

March 28, 2020

Study Completion

March 28, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

RU(2)