Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
Primary Purpose
Venous Insufficiency
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Flavonid
Daflon
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring Improvement of CVI parameters
Eligibility 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;
Sites / Locations
- Lal Clínica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flavonid
Daflon
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01110512
Brief Title
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Improvement of CVI parameters
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flavonid
Arm Type
Experimental
Arm Title
Daflon
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Flavonid
Intervention Description
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day.
Intervention Type
Drug
Intervention Name(s)
Daflon
Intervention Description
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day
Primary Outcome Measure Information:
Title
Improvement of the parameters of CVI, such as edema of lower members.
Description
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).
Time Frame
90 days.
Secondary Outcome Measure Information:
Title
Improvement of the parameters of CVI.
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Frederico, Psysician
Phone
55 19 3829-3822
Email
alexandre@lalclinica.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico, Doctor
Organizational Affiliation
LAL Clinical Reseach e Development Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lal Clínica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
SP
ZIP/Postal Code
13270000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico, Psysician
Phone
55 19 3829-3822
Email
alexandre@lalclinica.com.br
12. IPD Sharing Statement
Learn more about this trial
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
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