This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
Information provided by:
Azidus Brasil Identifier:
First received: April 19, 2010
Last updated: October 26, 2010
Last verified: April 2010
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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Improvement of the parameters of CVI, such as edema of lower members. [ Time Frame: 90 days. ]
    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 ]

    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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01110512

Contact: Alexandre Frederico, Psysician 55 19 3829-3822

Lal Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Psysician    55 19 3829-3822   
Sponsors and Collaborators
Azidus Brasil
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
  More Information

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT01110512     History of Changes
Other Study ID Numbers: FLANEO0210
Version 3
Study First Received: April 19, 2010
Last Updated: October 26, 2010

Keywords provided by Azidus Brasil:
Improvement of CVI parameters

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases processed this record on August 18, 2017