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

Study Overview
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Brief Summary
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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.

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Drug: Flavonid
* Drug: Daflon


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavonid<br> | Drug: Flavonid<br>* Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day.<br>|
| Active Comparator: Daflon<br> | Drug: Daflon<br>* Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Improvement of CVI parameters