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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04512443
Other study ID # Daflon25122019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Enrolling by invitation NCT02033863 - Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE N/A
Not yet recruiting NCT01909024 - Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent N/A
Completed NCT05889000 - Quality of Life Questionnaire and Disease Severity Scale
Completed NCT02796092 - Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome N/A
Completed NCT03921788 - Neuropeptides and Venous Pelvic Pain