Status:
UNKNOWN
Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Chronic Constipation
Hemorrhoids
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to assess the clinical efficacy and safety of the drug Imescard water smartweed compound pills in the treatment of patients with chronic constipation and hemorrhoidal dis...
Detailed Description
The Imescard compound water smartweed pills are currently registered in Brazil at the National Sanitary Surveillance Agency (ANVISA) as a laxative for the treatment of constipation, and as a supportin...
Eligibility Criteria
Inclusion
- age between 18 to 50;
- chronic constipation diagnosis by the American Association of Gastroentherology (AAG) criteria;
- clinical diagnosis of first and second degree hemorrhoids;
- good understanding and collaboration skills;
- correct fulfilling of the questionnaire at recruiting phase;
- absence of abnormalities in laboratory exams at recruiting phase;
- proper use of anticonceptives, in the case of women in fertile age;
- possibility of abstaining from other drugs (including non-medical ones) other than the intervention during the study, except in case of emergency and with the awareness of the responsible party in the study;
- signing informed consent form.
Exclusion
- Pregnant or lactating women;
- known hypersensitivity to any of the intervention's components;
- use of alcohol or illicit substances;
- clinical evidence of immunosuppression;
- diagnosis of any acute disease in activity or exacerbation of a chronic condition(uncontrolled), such as systemic arterial hypertension, ischemic cardiopathy, angle closure glaucoma, symptomatic prostatic hyperplasia, other concomitant anal disease as fissures, abscesses,fistulas,inflammatory bowel disease or colonic and rectal cancer, as well as any other condition that, in the investigator's opinion, may modify the study results unduly to the intervention being tested or that may put the patient in significant risk.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00861562
Start Date
April 1 2008
End Date
April 1 2009
Last Update
March 13 2009
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil