Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment

NCT ID: NCT00935948

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30

Brief 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.

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.

Conditions

Hemorrhoidal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Imescard ointment

Group Type: ACTIVE_COMPARATOR

Imescard compound water smartweed ointment

Intervention Type: DRUG

Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Imescard; Water smartweed ointment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

04497

Identifier Type: -

Identifier Source: org_study_id