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

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 March 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861562
First Posted: March 13, 2009
Last Update Posted: March 13, 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 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
Chronic Constipation Hemorrhoids Drug: Imescard water smartweed composed pills Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduction in colonic transit time assessed through radiologic technique. [ Time Frame: Day 5 and day 19. ]

Secondary Outcome Measures:
  • Daily evaluation of constipation and hemorrhoidal symptoms assessed by questionnaires. [ Time Frame: Daily from day 1 to 5 and from day 15 to 19. ]
  • Health quality improvement assessed by WHOQOL Brief at every followup visit. [ Time Frame: Days 1, 5, 15 and 19. ]
  • Adverse effects assessed by the investigator, blinded to the intervention, at every followup visit, through physical examination and laboratory exams. [ Time Frame: Days 1, 5, 15 and 19. ]

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
Active Comparator: Imescard pills/Placebo crossover
Patients received Imescard water smartweed composed pills during the first intervention period and placebo 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.
Active Comparator: Placebo/Imescard pills crossover
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.

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 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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): NCT00861562


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: NCT00861562     History of Changes
Other Study ID Numbers: 04372
First Submitted: March 12, 2009
First Posted: March 13, 2009
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
constipation
hemorrhoids
water smartweed
RCT

Additional relevant MeSH terms:
Constipation
Hemorrhoids
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases