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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.
A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endolex Forte® | Experimental | Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. |
|
| A combination of diosmin and hesperidin | Active Comparator | A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endolex Forte® | Dietary Supplement | Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume determination at day 180 (water displacement method) | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume determination at day 90 (water displacement method) | 90 days | |
| Change from pre-treatment (baseline) in the calf circumference on treatment day 30 | 30 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dionisio Barattini, MD | Contact | +39 335 5437574 | barattini@operacro.com | |
| Serban Rosu, MD | Contact | +40 722 313224 | rosu@operacro.com |
| Name | Affiliation | Role |
|---|---|---|
| Calin Giurcaneanu, MD | Spitalul Universitar de Urgenta Elias, Sectia Dermatologie | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15883226 | Background | Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available. | |
| 10355863 | Background | Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. doi: 10.1177/1358836X9900400101. |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006569 | Hesperidin |
| ID | Term |
|---|---|
| D044950 | Flavanones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| A combination of diosmin and hesperidin | Dietary Supplement | A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day. |
|
| Change from pre-treatment (baseline) in the calf circumference on treatment day 180 |
| 180 days |
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90 | 90 days |
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180 | 180 days |
| Global assessment of efficacy by the investigator at day 180 | 180 days |
| Questionnaire on improvement in symptoms at day 180 (CIVIQ-20) | 180 days |
| Global assessment of tolerability by the investigator at day 180 | 180 days |
| Adverse events | 180 days |
| 7707568 | Background | Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995 Apr;21(4):635-45. doi: 10.1016/s0741-5214(95)70195-8. |
| 20070899 | Background | Rabe E, Stucker M, Ottillinger B. Water displacement leg volumetry in clinical studies--a discussion of error sources. BMC Med Res Methodol. 2010 Jan 13;10:5. doi: 10.1186/1471-2288-10-5. |
| 21126890 | Background | Perrin M, Ramelet AA. Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):117-25. doi: 10.1016/j.ejvs.2010.09.025. Epub 2010 Dec 3. |
| 15387721 | Background | Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available. |
| 21768702 | Background | Sezer A, Usta U, Kocak Z, Yagci MA. The effect of a flavonoid fractions diosmin + hesperidin on radiation-induced acute proctitis in a rat model. J Cancer Res Ther. 2011 Apr-Jun;7(2):152-6. doi: 10.4103/0973-1482.82927. |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |