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

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00861562
• Other study ID #: 04372
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 12, 2009
• Last updated: March 12, 2009
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: March 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: April 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Hemorrhoids

Intervention

Drug:
• Imescard water smartweed composed pills
01 pill at every 8 hours for 5 days.
• Placebo
01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in colonic transit time assessed through radiologic technique.		Day 5 and day 19.	No
Secondary	Daily evaluation of constipation and hemorrhoidal symptoms assessed by questionnaires.		Daily from day 1 to 5 and from day 15 to 19.	No
Secondary	Health quality improvement assessed by WHOQOL Brief at every followup visit.		Days 1, 5, 15 and 19.	No
Secondary	Adverse effects assessed by the investigator, blinded to the intervention, at every followup visit, through physical examination and laboratory exams.		Days 1, 5, 15 and 19.	Yes