Overview

This trial is active, not recruiting.

Condition hemorrhoidal disease
Treatments imescard compound water smartweed ointment, placebo
Phase phase 3
Sponsor Hospital de Clinicas de Porto Alegre
Start date April 2008
End date May 2009
Trial size 60 participants
Trial identifier NCT00935948, 04497

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
imescard compound water smartweed ointment Imescard
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Age between 18 and 70 years old - 2nd to 4th degree hemorrhoids clinically diagnosed - Proper anticonception, in the case of women in fertile age - Possibility to abstain from any other drugs (except in emergencies, in wich case the responsible party must be informed) - Good understanding and agreement to informed consent form Exclusion Criteria: - Hypersensitivity to any of the components of the drug - Use of alcohol or drugs - Clinical evidence of immunosupression - Abnormalities in baseline laboratory exams - Diagnosis of any acute disease in current activity or chronic disease uncontrolled

Additional Information

Official title Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.