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To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.
Phlebotonics represent a heterogeneous group of therapeutic products of natural or synthetic origin that exhibit effects on edema and/or symptoms related to chronic venous diseaseThis class of drugs is effective in improving the symptoms of chronic venous insufficiency and in cases of hemorrhoids and for this reason they have become an established component of the therapeutic arsenal for all phases of these diseases Phlebotomics are classified into four categories: benzopyrones, saponins, other plant extracts, and synthetic drugs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina | Experimental | Aesculus hippocastanum 50mg, Polygonum acre 10mg, Smilax Pepyracea 40mg, Rutina 20mg |
|
| Diosmina, and Hesperidina | Active Comparator | Diosmina 450mg e Hesperidina 50mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aesculus hippocastanum, and associations | Drug | combination product |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogic scale | A 100 mm VAS (visual analogic scale) is marked from 0 (absence of venous symptoms) up to 100 (maximum symptomatic venous manifestations) by the patient (higher scores means a worse outcome). It is fulfilled by the patient him- or herself, under the physician's watch. VAS is meant to globally evaluate lower limbs venous symptomatology (heavy legs, painful legs, fatigued legs, deambulation limitations, swollen sensation and/or lower limbs tension). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral acceptability by the patient through the use of a visual analogic scale | A 100 mm VAS (visual analogic scale) is marked from 0 (easy swallowing) up to 100 (very difficult to swallow) by the patient (higher scores means a worse outcome). It is fulfilled under by the patient him- or herself under the physician's watch. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
10. Patient with a change in general condition that is incompatible with his/her participation in the study 11. Patient who wishes to become pregnant within 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Nunes, Professor | Fundação Educacional Serra dos Órgãos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitário Serra dos Órgãos - UNIFESO | Teresópolis | Rio de Janeiro | 25964004 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18276714 | Background | Acheson AG, Scholefield JH. Management of haemorrhoids. BMJ. 2008 Feb 16;336(7640):380-3. doi: 10.1136/bmj.39465.674745.80. No abstract available. | |
| 23761871 | Background | Belczak SQ, Sincos IR, Campos W, Beserra J, Nering G, Aun R. Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial. Phlebology. 2014 Aug;29(7):454-60. doi: 10.1177/0268355513489550. Epub 2013 May 16. |
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| ID | Term |
|---|---|
| C517354 | horse chestnut seed |
| D001244 | Association |
| ID | Term |
|---|---|
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized, non-inferiority, double-blind ,comparative study
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coated tablets
|
| Quality of life as measured by a specific chronic venous insufficiency questionnaire |
CIVIQ-10 (chronIc venous insufficiency quality of life questionnaire) is a questionnaire composed of 20 scored items (on a 4 point scale) that inform on the capacity of the patient of coping with daily routine tasks, regarding their lower limbs venous competence. The higher the score, the better the clinical outcome. |
| 3 months |
| Medical tolerability to tested drugs as measured by the investigator | Tolerability will be a measure of the nature and quantity of adverse clinical and lab reactions related to study drugs. | 3 months |
| Patient's satisfaction to study medications | This endpoint regards to the medication's efficacy as perceived by the patient and graduated as: "insufficient", "acceptable", "good", or "very good". | 3 months |
| Physician's satisfaction to study medications | This endpoint regards to the medication's efficacy as perceived by the investigating physician and graduated as: "insufficient", "acceptable", "good", or "very good". | 3 months |
| 12936900 | Background | Criqui MH, Jamosmos M, Fronek A, Denenberg JO, Langer RD, Bergan J, Golomb BA. Chronic venous disease in an ethnically diverse population: the San Diego Population Study. Am J Epidemiol. 2003 Sep 1;158(5):448-56. doi: 10.1093/aje/kwg166. |
| 16119324 | Background | Kecmanovic D, Pavlov M, Ceranic M, Sepetkovski A, Kovacevi P, Stamenkovic A. [PHLEBODIA (diosmine): a role in the management of bleeding nonprolapsed hemorrhoids]. Acta Chir Iugosl. 2005;52(1):115-6. doi: 10.2298/aci0501115k. Serbian. |
| 7798803 | Background | Lafuma A, Fagnani F, Peltier-Pujol F, Rauss A. [Venous disease in France: an unrecognized public health problem]. J Mal Vasc. 1994;19(3):185-9. French. |
| 18277340 | Background | Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available. |
| 22466974 | Background | Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15. |
| 8995346 | Background | Ruckley CV. Socioeconomic impact of chronic venous insufficiency and leg ulcers. Angiology. 1997 Jan;48(1):67-9. doi: 10.1177/000331979704800111. |
| 22895941 | Background | Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3. |