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

Venous Insufficiency Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01110512
• Other study ID #: FLANEO0210
• Secondary ID: Version 3
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 19, 2010
• Last updated: October 26, 2010
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, Psysician
• Phone: 55 19 3829-3822
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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;

Study Design

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

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Drug:
• Flavonid
Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day.
• Daflon
Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day

Locations

Country	Name	City	State
Brazil	Lal Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the parameters of CVI, such as edema of lower members.	There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).	90 days.	No
Secondary	Improvement of the parameters of CVI.	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.	90 days	No