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Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935948
First Posted: July 9, 2009
Last Update Posted: July 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition Intervention Phase
Hemorrhoidal Disease Drug: Imescard compound water smartweed ointment Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935948


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
  More Information

Responsible Party: Paulo Dornelles Picon, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00935948     History of Changes
Other Study ID Numbers: 04497
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: July 9, 2009
Last Verified: July 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
hemorrhoids
hemorrhoidal disease
water smartweed
hamamelis
RCT