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Completed

NCT Number: NCT04512443

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

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 .

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Key information

Conditions

Pelvic Congestion Syndrome

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Akhmetzianov Rustem, Kazan', Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Pelvic Varicose Veins Questionnaire

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Interregional Clinical Diagnostic Center, Russia

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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