Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment

Hemorrhoidal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00935948
• Other study ID #: 04497
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 8, 2009
• Last updated: July 8, 2009
• Start date: April 2008

Study information

• Verified date: July 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoidal Disease

Intervention

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
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Mean scores of the symptom questionnaires mentioned above.		Days 1 to 5.	No
Secondary	Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.		Days 1 and 8.	No
Secondary	Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.		Day 8	Yes