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

Pelvic Congestion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512443
• Other study ID #: Daflon25122019
• Status: Completed
• Start date: December 28, 2019
• Est. completion date: March 28, 2020

Study information

• Verified date: August 2020
• Source: Interregional Clinical Diagnostic Center, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Congestion Syndrome
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Russian Federation	Akhmetzianov Rustem	Kazan
Russian Federation	Roman Bredikhin	Kazan

Sponsors (1)

Lead Sponsor	Collaborator
Interregional Clinical Diagnostic Center, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Varicose Veins Questionnaire	Assessment of quality of life according to the questionnaire before and after treatment	2 months