Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment
Recruitment status was: Active, not recruiting
|Hemorrhoidal Disease||Drug: Imescard compound water smartweed ointment Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment|
- 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 ]
|Study Start Date:||April 2008|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Imescard ointment||
Drug: Imescard compound water smartweed ointment
Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.
|Placebo Comparator: Placebo||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935948
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil|