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

Completed

• Conditions: Pelvic Congestion Syndrome
• Interventions: Drug: Daflon

• Registration Number: NCT04512443
• Lead Sponsor: Interregional Clinical Diagnostic Center, Russia

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 available

Study Timeline

• Study Start: 2019-12-28
• Primary Completion: 2020-03-28
• Study Completion: 2020-03-28
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Daflon	42 women (treated with Daflon 1000 mg (study group))

Primary Outcome Measures

Name	Time	Method
Pelvic Varicose Veins Questionnaire	2 months	Assessment of quality of life according to the questionnaire before and after treatment

Trial Locations

Locations (2)

Akhmetzianov Rustem; 🇷🇺 Kazan, Russian Federation

Roman Bredikhin; 🇷🇺 Kazan, Russian Federation