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 L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01110512
First received: April 19, 2010
Last updated: October 26, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Insufficiency |
Drug: Flavonid Drug: Daflon |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
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);
- Itching;
- Pain;
- cramps at night;
- Discomfort functional;
- Heaviness.
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110512
Contacts
| Contact: Alexandre Frederico, Psysician | 55 19 3829-3822 | alexandre@lalclinica.com.br |
Locations
| Brazil | |
| Lal Clínica Pesquisa e Desenvolvimento Ltda | Not yet recruiting |
| Valinhos, SP, Brazil, 13270000 | |
| Contact: Alexandre Frederico, Psysician 55 19 3829-3822 alexandre@lalclinica.com.br | |
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
| Principal Investigator: | Alexandre Frederico, Doctor | LAL Clinical Reseach e Development Ltda |
More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT01110512 History of Changes |
| Other Study ID Numbers: | FLANEO0210, Version 3 |
| Study First Received: | April 19, 2010 |
| Last Updated: | October 26, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
Improvement of CVI parameters |
Additional relevant MeSH terms:
|
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013