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

Phase 3

• Conditions: Venous Insufficiency
• Interventions: Drug: Flavonid; Drug: Daflon

• Registration Number: NCT01110512
• Lead Sponsor: Azidus Brasil

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27
• Primary Completion: 2010-12
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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;

Read More

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;

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flavonid	Flavonid	-
Daflon	Daflon	-

Primary Outcome Measures

Name	Time	Method
Improvement of the parameters of CVI, such as edema of lower members.	90 days.	There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).

Secondary Outcome Measures

Name	Time	Method
Improvement of the parameters of CVI.	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.

Trial Locations

Locations (1)

Lal Clínica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil