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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Venous Insufficiency, Disease

Intervention / Treatment
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* Drug: Daflon
* Drug: Venaflon (Diosmin and Hesperidin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venafon (Diosmin and Hesperidin)<br>Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). | Drug: Daflon<br>* Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).<br>|
| Active Comparator: Daflon<br>Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). | Drug: Venaflon (Diosmin and Hesperidin)<br>* Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3 | To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify adverse events, as well as their frequency and causality related to study medication. | The secondary outcome measure will be to evaluate the tolerability of Venaflon in the symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic venous insufficiency, Daflon, Venaflon