Clinical Efficacy of Conservative Treatment in Female Pat... | NCT04512443

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

NCT04512443

Sponsor

Interregional Clinical Diagnostic Center, Russia

Status

Completed

Last Update Posted

Aug 13, 2020Actual

Enrollment

83Actual

Phase

Not provided

Conditions

Pelvic Congestion Syndrome

Interventions

Daflon

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2019Actual

Primary Completion Date

Mar 28, 2020Actual

Completion Date

Mar 28, 2020Actual

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 12, 2020

First Posted Date

Aug 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akhmetzianov Rustem, Principal Investigator, Interregional Clinical Diagnostic Center, RussiaPrincipal Investigator

Lead Sponsor

Interregional Clinical Diagnostic Center, RussiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		42 women (treated with Daflon 1000 mg (study group))	Drug: Daflon
2		41 women (placebo (control group))

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daflon	Drug	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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

women with Pelvic congestion syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akhmetzianov Rustem		Kazan'		420097	Russia
Roman Bredikhin

Intervention Browse Module

MeSH Terms

ID	Term
D004145	Diosmin

Ancestor Terms

ID	Term
D047309	Flavones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

Browse Leaves

Not provided

Browse Branches

Not provided