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| ID | Type | Description | Link |
|---|---|---|---|
| 83102224.6.0000.5247 | Other Identifier | Certificado de Apresentação de Apreciação Ética - Anvisa |
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| Name | Class |
|---|---|
| Universidade Federal do Rio de Janeiro | OTHER |
| Universidade Federal Fluminense | OTHER |
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To demonstrate the clinical efficacy of the combination of Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and rutin in tablets in improving local symptoms (bleeding, pain, thrombosis, perianal dermatitis, hemorrhoidal nipple prolapse) assessed using a 100mm visual scale (VAS) over 60 days among adult patients with grade 1, 2 or 3 hemorrhoidal disease.
Hemorrhoidal disease (HD) is the most common proctological condition, with an up to 86% prevalence (asymptomatic individuals underestimated). It is expected that 5% of the population might have at least one episode of HD during their lifetime, most individuals amenable to medical therapy but 10 to 20% of them requiring surgical intervention. HD has an occurrence peak between the 5th and 7th decades of life. Haemorrhoids can be defined as varicose dilatation of the submucosal anorectal veins due to persistently elevated venous pressure in the hemorrhoidal plexus, that is, they develop when the venous drainage of the anus and rectum is altered, causing dilatation of the venous plexus and connective tissue, creating an overgrowth of the anal mucosa of the rectal wall. The term HD is used when haemorrhoids cause symptoms. Aesculus hippocastanum (horse chestnut), rutin, Smilax papyracea (sarsaparilla), Polygonum acre (dotted smartweed) combination is commonly used to control chronic venous insufficiency (CVI) manifestations. Assuming pathophysiology of HD and CVI are similar, the investigators hypothesized the above combination could be also useful in the management of the former condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesculus hippocastanum, and interventions | Other | Self-paired study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aesculus hippocastanum, and interventions | Drug | venotonic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhoidal Disease Symptom Score (HDSS) (adapted) | 4 questions:
Possible answers:
| 2 months |
| Short Health Scale HD (SHSHD) |
Possible answers:
| 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| global satisfaction of the patient | Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below:
| 3 months |
| global satisfaction of the physician |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in hemorrhoidal symptoms | The 100mm visual scale is assessed by the patient between "0" = absence of venous symptoms and "100" = maximum intensity of symptoms. The visual scale is performed by the patient in the presence of the investigator. This visual scale assesses the symptoms of haemorrhoidal disease in a global manner: bleeding, pain, thrombosis, perianal dermatitis (pruritus or anal discomfort), prolapse of the hemorrhoidal nipple, soiling. |
Inclusion Criteria:
Exclusion Criteria:
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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. | |
| 21472103 | Background | Ba-bai-ke-re MM, Huang HG, Re WN, Fan K, Chu H, Ai EH, Li-Mu MM, Wang YR, Wen H. How we can improve patients' comfort after Milligan-Morgan open haemorrhoidectomy. World J Gastroenterol. 2011 Mar 21;17(11):1448-56. doi: 10.3748/wjg.v17.i11.1448. |
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| ID | Term |
|---|---|
| C517354 | horse chestnut seed |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below:
| 3 months |
| 3 months |
| 1302317 | Background | Bartolo M. [Socioeconomic impact of venous diseases in Italy]. Phlebologie. 1992 Nov-Dec;45(4):423-31. French. |
| 17653022 | Background | Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. Minerva Cardioangiol. 2007 Aug;55(4):459-76. No abstract available. English, Italian. |
| 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. |
| 30276625 | Background | Zagriadskii EA, Bogomazov AM, Golovko EB. Conservative Treatment of Hemorrhoids: Results of an Observational Multicenter Study. Adv Ther. 2018 Nov;35(11):1979-1992. doi: 10.1007/s12325-018-0794-x. Epub 2018 Oct 1. |
| 15364642 | Result | Dickson S, Gallagher J, McIntyre L, Suter A, Tan J. An open study to assess the safety and efficacy of Aesculus hippocastanum tablets (Aesculaforce 50mg) in the treatment of chronic venous insufficiency. J Herb Pharmacother. 2004;4(2):19-32. |
| 25022355 | Result | Park G, Kim TM, Kim JH, Oh MS. Antioxidant effects of the sarsaparilla via scavenging of reactive oxygen species and induction of antioxidant enzymes in human dermal fibroblasts. Environ Toxicol Pharmacol. 2014 Jul;38(1):305-15. doi: 10.1016/j.etap.2014.06.009. Epub 2014 Jun 28. |
| 30451751 | Result | Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234. |
| 22895941 | Result | 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. |