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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Insufficiency
• Intervention / Treatment: Drug: Flavonid; Drug: Daflon

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandre Frederico, Psysician; Phone Number: 55 19 3829-3822; Email: alexandre@lalclinica.com.br

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda
      • Contact: Alexandre Frederico, Psysician; Phone Number: 55 19 3829-3822; Email: alexandre@lalclinica.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Principal Investigator: Alexandre Frederico, Doctor, LAL Clinical Reseach e Development Ltda

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Improvement of CVI parameters
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: FLANEO0210; version 3 (Protocol Version)