Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.