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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.
"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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venafon (Diosmin and Hesperidin) | Experimental | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). |
|
| Daflon | Active Comparator | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daflon | Drug | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Venaflon (Diosmin and Hesperidin) | Drug | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). |
|
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D006569 | Hesperidin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D044950 | Flavanones |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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