Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Azidus Brasil.
Recruitment status was Not yet recruiting
Information provided by:
First received: April 19, 2010
Last updated: October 26, 2010
Last verified: April 2010
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Primary Outcome Measures:
- Improvement of the parameters of CVI, such as edema of lower members. [ Time Frame: 90 days. ] [ Designated as safety issue: No ]
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).
Secondary Outcome Measures:
- Improvement of the parameters of CVI. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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);
- cramps at night;
- Discomfort functional;
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day.
Active Comparator: Daflon
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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;
- 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;
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01110512
|Lal Clínica Pesquisa e Desenvolvimento Ltda
|Valinhos, SP, Brazil, 13270000 |
|Contact: Alexandre Frederico, Psysician 55 19 3829-3822 firstname.lastname@example.org |
||Alexandre Frederico, Doctor
||LAL Clinical Reseach e Development Ltda
||Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 19, 2010
||October 26, 2010
||Brazil: National Health Surveillance Agency
Keywords provided by Azidus Brasil:
Improvement of CVI parameters
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 22, 2016