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Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility.
Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).
The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diosmin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmin | Drug | tablet, 600mg, PO, 1 tab per day during 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Visual analog Scale score for assessment of the painful venous symptomatology | baseline and after 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| - Painful symptom intensity (daily VAS score) Area Under the Curve | 28 days | |
| - Daily VAS score for Response rate | 28 days | |
| - Daily VAS score for Time to response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jérôme GUEX, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Jean-Jérôme GUEX | Nice | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33141449 | Derived | Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4. |
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| Placebo |
| Drug |
tablet, PO, 1 per day during 28 days |
|
| 28 days |
| - Score of Quality of life questionnaire (SQOR-V) | Between baseline and 28 days |
| - Patient's and physician's global satisfaction score | At 28 days |
| Adverse Events (numbers and frequency) | 28 days |
| - Unusual intakes of analgesic treatments (rate of patients) | 28 days |
| ID | Term |
|---|---|
| D004145 | Diosmin |
| 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 |
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