Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon

Laboratório Teuto Brasileiro

Status and phase

Unknown

Phase 3

Conditions

Disease

Chronic Venous Insufficiency

Treatments

Drug: Venaflon (Diosmin and Hesperidin)

Drug: Daflon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01477281

E01-TEU-VEN-08-10

Details and patient eligibility

About

The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.

Full description

"A clinical multicenter, phase III, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of Venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with Daflon."

Enrollment

82 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years
Women and men of childbearing age who agree to use acceptable contraception throughout the study.
Be patient with chronic venous insufficiency of lower limbs varicose comDiagnostico clinical CEAP 0-3 by CEAP
Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 4, as measured by visual analog scale
Being the 7 days without any medication or treatment related to the venous system.
Patients able to make proper use of medication
Patients who consent to participate in the study by signing the Instrument of Consent.

Exclusion criteria

Pregnant or breastfeeding women
Women who are breastfeeding
Women and men of childbearing age who do not accept to use acceptable contraception throughout the study
Patients under 18 or over 65 years
Patients with a history of hypersensitivity to any component of the formula
Presence of signs and symptoms of different conditions of venous disease to justify the pain or swelling
Use of elastic compression in the last two weeks
Venous obstruction of the lower limbs
Patients who have previously used or Venaflon Daflon and did not benefit;
Deep vein thrombosis in the last 6 months before entering the study;
Use of diuretics in the last 4 weeks
Previous venous surgery
Patients with renal and liver failure
Patients with gastritis or gastric ulcer
Patients with blood clotting disorders
Any condition which in the opinion of the physician researcher is significant and can make the patient unsuitable for study or you can place it under additional risk