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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01110512
First received: April 19, 2010
Last updated: October 26, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Venous Insufficiency
Drug: Flavonid
Drug: Daflon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Improvement of the parameters of CVI, such as edema of lower members. [ Time Frame: 90 days. ] [ Designated as safety issue: No ]
    There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).


Secondary Outcome Measures:
  • Improvement of the parameters of CVI. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

    There will be 06 planned visits (V0, V1, V2, V3, V4 and V5). Assessment of improvement of signs and symptoms secondary to IVC, which are:

    • paresthesia (tingling);
    • Itching;
    • Pain;
    • cramps at night;
    • Discomfort functional;
    • Heaviness.


Estimated Enrollment: 140
Study Start Date: October 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flavonid Drug: Flavonid

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day.

Active Comparator: Daflon Drug: Daflon

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 lower limbs;
  • 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 study questionnaires;
  • Subjects who agree to make any return visits for evaluation;

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 use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding 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 to be excluded;
  • Pregnant or nursing women;
  • Presence of any medical condition that, according to the investigator, should prevent the 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 or liver disease);
  • Values of laboratory tests appropriate security; the Hemoglobin <10 mg / mL the creatinine> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 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 classes of substances under investigation;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110512

Contacts
Contact: Alexandre Frederico, Psysician 55 19 3829-3822 alexandre@lalclinica.com.br

Locations
Brazil
Lal Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Psysician    55 19 3829-3822    alexandre@lalclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01110512     History of Changes
Other Study ID Numbers: FLANEO0210, Version 3
Study First Received: April 19, 2010
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Improvement of CVI parameters

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014