Clinical study
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
Itching
Ooozing
Pain
Bleeding
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.