Status:
COMPLETED
Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency
Lead Sponsor:
Fundação Educacional Serra dos Órgãos
Conditions:
Venous Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, singl...
Detailed Description
The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower l...
Eligibility Criteria
Inclusion
- Patients of both genders \>18 years old
- Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
- Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
- Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
- Subject has read, understood, dated and signed the informed consent form
Exclusion
- Treatment by compression stocking within the 2 months before inclusion
- Treatment by venotonics within the 2 months before inclusion
- Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
- Known allergy or hypersensitivity to any component of the study drug
- Known clinically significant laboratory alterations
- CEAP levels 4, 5 \& 6
- Patient with venous disease requiring surgery / chemical endovenous sclerotherapy
- Patient suffering from a painful pathology other than the venous pain in the lower limbs
- Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion
- Patient with alteration of general condition incompatible with his / her participation in the trial
- Patient wishing to be pregnant in the 6 following months
Key Trial Info
Start Date :
June 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03471910
Start Date
June 20 2017
End Date
April 30 2018
Last Update
June 20 2018
Active Locations (1)
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1
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, Brazil, 25964004