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Sponsored by: |
Hospital de Clinicas de Porto Alegre |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00861562 |
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.
Condition | Intervention | Phase |
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Chronic Constipation Hemorrhoids |
Drug: Imescard water smartweed composed pills Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills |
Enrollment: | 56 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Imescard pills/Placebo crossover: Active Comparator
Patients received Imescard water smartweed composed pills during the first intervention period and placebo during the second, after a 10-day washout period.
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Drug: Imescard water smartweed composed pills
01 pill at every 8 hours for 5 days.
Drug: Placebo
01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.
|
Placebo/Imescard pills crossover: Active Comparator
Patients received placebo during the first intervention period and Imescard water smartweed composed pills during the second, after a 10-day washout period.
|
Drug: Imescard water smartweed composed pills
01 pill at every 8 hours for 5 days.
Drug: Placebo
01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.
|
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 supporting drug in hemorrhoid treatment. Though water smartweed (Polygonum hydropiperoides) has been used throughout the years as an antiinflammatory and in hemorrhoidal treatment, there are no reliable pharmacologic and clinical evidence that demonstrate its efficacy. The aim of this study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed pills in the treatment of chronic constipation and hemorrhoidal disease in a randomized, double-blind, crossover, placebo-controlled clinical trial.
Volunteers underwent a clinical evaluation and laboratory exams at enrollment, and 56 patients met the inclusion criteria and agreed to sign the informed consent form. Participants were then randomized into two groups to receive either Imescard pills or placebo, identical in appearance, once at every 8 hours for five days, followed by a 10-day washout period, and then received the other intervention for another 5-day period.
Followup visits were performed at day 1, 5, 15, and 19. At the beginning of each intervention period(days 1 and 15), patients were given diaries that included two questionnaires for each day of treatment, concerning constipation and hemorrhoidal symptoms, and received the intervention, unaware of its content. Colonic transit time was assessed at the end of each intervention period (days 5 and 19) through standard radiologic technique, and laboratory exams were taken three days later. Clinical evaluation and adverse effects assessment was performed at every visit by blinded investigator, and patients also fulfilled WHOQOL Brief, for life quality assessment.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital de Clínicas de Porto Alegre ( Paulo Dornelles Picon ) |
Study ID Numbers: | 04372 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861562 History of Changes |
Health Authority: | Brazil: Ethics Committee |
constipation hemorrhoids water smartweed RCT |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases Vascular Diseases |
Constipation Hemorrhoids Intestinal Diseases Rectal Diseases |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases Vascular Diseases |
Hemorrhoids Constipation Cardiovascular Diseases Intestinal Diseases Rectal Diseases |