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

NCT ID: NCT01110512

Last Updated: 2010-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

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.

Detailed Description

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Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Flavonid

Group Type EXPERIMENTAL

Flavonid

Intervention Type DRUG

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day.

Daflon

Group Type ACTIVE_COMPARATOR

Daflon

Intervention Type DRUG

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day

Interventions

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Flavonid

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day.

Intervention Type DRUG

Daflon

Diosmin (450 mg) + hesperidin (50 mg)

1 tablet, 2 times per day

Intervention Type DRUG

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clinica Pesquisa e Desenvolvimento Ltda

Principal Investigators

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Alexandre Frederico, Doctor

Role: PRINCIPAL_INVESTIGATOR

LAL Clinical Reseach e Development Ltda

Locations

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Lal Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Alexandre Frederico, Psysician

Role: CONTACT

[email protected]
55 19 3829-3822

Facility Contacts

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Alexandre Frederico, Psysician

Role: primary

[email protected]
55 19 3829-3822

Other Identifiers

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Version 3

Identifier Type: -

Identifier Source: secondary_id

FLANEO0210

Identifier Type: -

Identifier Source: org_study_id