Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)

Last updated: October 26, 2010
Sponsor: Azidus Brasil
Overall Status: Trial Status Unknown

Phase

3

Condition

Varicose Veins

Vascular Diseases

Claudication

Treatment

N/A

Clinical Study ID

NCT01110512
FLANEO0210
Version 3
  • Ages 18-75
  • All Genders

Study Summary

It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who agree to the terms described in IC;

  • Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lowerlimbs;

  • Subjects with CVI ranked 3 to 5, according to CEAP scale;

  • Patients complaining of pain and swelling in the lower limbs secondary to IVC;

  • Subjects with good mental health that can respond adequately to the studyquestionnaires;

  • Subjects who agree to make any return visits for evaluation;

Exclusion

Exclusion Criteria:

  • Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;

  • Subjects who have received treatment for varicose veins as laser, medication usetopical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 monthspreceding the study;

  • Patients with other diseases that may interfere with the study results: thrombosis,coagulation disorders and other diseases that the medical criteria, are important tobe excluded;

  • Pregnant or nursing women;

  • Presence of any medical condition that, according to the investigator, should preventthe patient from the study;

  • Participation in clinical trials in the twelve months preceding the study;

  • Patients with serious illnesses and uncontrolled that need multidrug treatment;

  • Patients on diuretics of any kind, regardless of pathology (hypertension, renal orliver disease);

  • Values of laboratory tests appropriate security; the Hemoglobin <10 mg / mL thecreatinine> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet countbelow 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.

  • past medical history of hypersensitivity to drugs of the same pharmacological classesof substances under investigation;

Study Design

Total Participants: 140
Study Start date:
October 01, 2010
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Lal Clínica Pesquisa e Desenvolvimento Ltda

    Valinhos, SP 13270000
    Brazil

    Site Not Available

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