A Phase 3 interventional study of Imescard compound water smartweed ointment and Placebo in Hemorrhoidal Disease, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-09.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 3, Interventional, and Treatment
The aim of our study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
The drug Imescard compound water smartweed ointment is currently registered at the brazilian National Sanitary Surveillance Agency (ANVISA) as a topic hemorrhoidal treatment. It's composed by adrenalin, which produces vasoconstriction, benzocaine, an anesthetic, hamamelis, which is believed to have a desiccative and astringent activity, and water smartweed (Polygonum hydropiperoides), commonly used in the treatment of this condition, with, however, little or no evidence other than tradition to support its use. The aim of this study was to assess the clinical efficacy and safety of this drug in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
Sixty healthy volunteers with ages between 18 to 70 years old who presented with 2nd to 4th degree hemorrhoids were enrolled after clinical and laboratory evaluation (day 0) and then randomized (day 1) to receive either the Imescard ointment after waking up, after evacuations and before bedtime, for 5 days, or placebo, with the exact same appearance and posology. At followup (day 8), patients underwent new clinical and laboratory evaluation. Main outcome was the percentage of patients with 50% improval of symptoms, assessed by a diary containing symptom questionnaires concerning every day of treatment. Secondary outcomes were mean scores of the symptom questionnaires, life quality improval assessed by WHOQOLbrief at days 1 and 8 and adverse effects evaluation.
Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Drug: Imescard compound water smartweed ointment
Drug: Placebo
Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.
Also known as: Imescard, Water smartweed ointment
Patients in this arm received placebo, with the exact same appearance of the Imescard ointment, and were instructed to apply it at the same intervals and period.
Improval of 50% or more in hemorrhoidal symptoms, assessed by questionnaires concerning pain, swelling, secretion and bleeding of hemorrhoids, contained in a diary that patients were instructed to fulfill daily during the treatment.
Time frame: Days 1 to 5.
Mean scores of the symptom questionnaires mentioned above.
Time frame: Days 1 to 5.
Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.
Time frame: Days 1 and 8.
Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.
Time frame: Day 8
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre