Basic study information
|Name of study:||Biomedical research regarding the efficacy of haemorrhoidal disease treatment|
|Type of study:||Biomedical research of non-interventional clinical trial type - study|
|Authorizing officer:||BSK - Ethics Committee (13 members)|
|The aim of study:||Evaluation of the clinical efficacy of medical device RECTOVENAL® Acute in adults patients with haemorrhoidal disease and focus mainly on the acute phase of an attack of a haemorrhoidal disease.|
|Duration:||October 2015 – December 2015 (8 weeks)|
|Respondents:||395 distributed questionnaires - 328 completed (203 women, 125 males, aged 14-95)|
|Dosage:||Patients will be given a free sample of RECTOVENAL® Acute with reccomended dosage 5-7 days in the morning and at bedtime, followed by 2-3 times a week until singns have cleared. Every patient got a questionnaire, which should be completed after using.|
|Multicenter:||5 ambulances, 8 pharmacies|
|Blinding:||Opened, non-placebo controlled|
|Randomized:||Based on the recommendation of a physician/pharmacist, on a voluntary basis|
Study result for the observed symptomms
Clincal study result
CLINICAL EFFICIENCY of the RECTOVENAL® Acute medical device in adult patients suffering from hemorrhoidal disease with accent to the acute phase of hemorrhoidal attack >WAS CONFIRMED>.
MORE THAN 70% PATIENTs* has experienced disappearance or significant decrease in unpleasant symptoms of hemorrhoidal disease such as itching, sores, pain, bleeding, burning and irritation within 1 hour* from RECTOVENAL® Acute application.