Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment

Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoidal Disease
• Intervention / Treatment: Drug: Imescard compound water smartweed ointment; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: 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.
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.; Other Names: Imescard; Water smartweed ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Days 1 to 5.

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean scores of the symptom questionnaires mentioned above.	Days 1 to 5.
Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.	Days 1 and 8.
Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.	Day 8

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (ESTIMATE): July 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: RCT; hemorrhoids; hemorrhoidal disease; water smartweed; hamamelis
• Other Study ID Numbers: 04497