Status:
UNKNOWN
Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Hemorrhoidal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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, ...
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 adrenali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00935948
Start Date
April 1 2008
Last Update
July 9 2009
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil