Chronic ConstipationPhase 3NCT00861562
Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills
A Phase 3 study testing Imescard water smartweed composed pills in people with Chronic Constipation and Hemorrhoids, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Constipation, Hemorrhoids
- What is being tested?
- Imescard water smartweed composed pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
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.
Read the 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.
- Conditions
- Chronic Constipation, Hemorrhoids
- Being tested
- Imescard water smartweed composed pills, Placebo
- Keywords
- constipation, hemorrhoids, water smartweed, RCT
- Medical subject headings
- Hemorrhoids, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imescard water smartweed composed pillsDrug
01 pill at every 8 hours for 5 days.
PlaceboDrug
01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Imescard water smartweed composed pills; Drug: Placebo |
| 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. Receives: Drug: Imescard water smartweed composed pills; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in colonic transit time assessed through radiologic technique.
Measured: Day 5 and day 19.
Secondary outcomes (3)
Daily evaluation of constipation and hemorrhoidal symptoms assessed by questionnaires.
Measured: Daily from day 1 to 5 and from day 15 to 19.
Health quality improvement assessed by WHOQOL Brief at every followup visit.
Measured: 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.
Measured: Days 1, 5, 15 and 19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861562
- Sponsor's protocol ID
- 04372
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed Pills
- ClinicalTrials.gov ID
- NCT00861562
- Acronym / sponsor ID
- 04372
- Conditions
- Chronic Constipation, Hemorrhoids
- Keywords
- constipation, hemorrhoids, water smartweed, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imescard pills/Placebo crossover | Active comparator | Drug: Imescard water smartweed composed pills, Drug: PlaceboPatients received Imescard water smartweed composed pills during the first intervention period and placebo during the second, after a 10-day washout period. |
| Placebo/Imescard pills crossover | Active comparator | Drug: Imescard water smartweed composed pills, Drug: PlaceboPatients received placebo during the first intervention period and Imescard water smartweed composed pills during the second, after a 10-day washout period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imescard water smartweed composed pills01 pill at every 8 hours for 5 days. | Drug | Imescard pills/Placebo crossover, Placebo/Imescard pills crossover |
| Placebo01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention. | Drug | Imescard pills/Placebo crossover, Placebo/Imescard pills crossover |
Primary outcome
Reduction in colonic transit time assessed through radiologic technique.
Time frame: Day 5 and day 19.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imescard water smartweed composed pills in people with Chronic Constipation and Hemorrhoids, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in colonic transit time assessed through radiologic technique. (time frame: Day 5 and day 19.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2009.