Hemorrhoidal DiseasePhase 3NCT00935948
Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment
A Phase 3 study testing Imescard compound water smartweed ointment in people with Hemorrhoidal Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of our study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoidal Disease
- What is being tested?
- Imescard compound water smartweed ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to May 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old
- 2nd to 4th degree hemorrhoids clinically diagnosed
- Proper anticonception, in the case of women in fertile age
- Possibility to abstain from any other drugs (except in emergencies, in wich case the responsible party must be informed)
- Good understanding and agreement to informed consent form
Who cannot join
- Hypersensitivity to any of the components of the drug
- Use of alcohol or drugs
- Clinical evidence of immunosupression
- Abnormalities in baseline laboratory exams
- Diagnosis of any acute disease in current activity or chronic disease uncontrolled
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
Official title: Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment
The aim of our study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
Read the detailed description
The drug Imescard compound water smartweed ointment is currently registered at the brazilian National Sanitary Surveillance Agency (ANVISA) as a topic hemorrhoidal treatment. It's composed by adrenalin, which produces vasoconstriction, benzocaine, an anesthetic, hamamelis, which is believed to have a desiccative and astringent activity, and water smartweed (Polygonum hydropiperoides), commonly used in the treatment of this condition, with, however, little or no evidence other than tradition to support its use. The aim of this study was to assess the clinical efficacy and safety of this drug in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
Sixty healthy volunteers with ages between 18 to 70 years old who presented with 2nd to 4th degree hemorrhoids were enrolled after clinical and laboratory evaluation (day 0) and then randomized (day 1) to receive either the Imescard ointment after waking up, after evacuations and before bedtime, for 5 days, or placebo, with the exact same appearance and posology. At followup (day 8), patients underwent new clinical and laboratory evaluation. Main outcome was the percentage of patients with 50% improval of symptoms, assessed by a diary containing symptom questionnaires concerning every day of treatment. Secondary outcomes were mean scores of the symptom questionnaires, life quality improval assessed by WHOQOLbrief at days 1 and 8 and adverse effects evaluation.
- Conditions
- Hemorrhoidal Disease
- Being tested
- Imescard compound water smartweed ointment, Placebo
- Keywords
- hemorrhoids, hemorrhoidal disease, water smartweed, hamamelis, RCT
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imescard compound water smartweed ointmentDrug
Also called Imescard, Water smartweed ointment
Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.
PlaceboDrug
Patients in this arm received placebo, with the exact same appearance of the Imescard ointment, and were instructed to apply it at the same intervals and period.
| Study group | Role | What they receive |
|---|---|---|
| Imescard ointment | Active comparator | Not described Receives: Drug: Imescard compound water smartweed ointment |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improval of 50% or more in hemorrhoidal symptoms, assessed by questionnaires concerning pain, swelling, secretion and bleeding of hemorrhoids, contained in a diary that patients were instructed to fulfill daily during the treatment.
Measured: Days 1 to 5.
Secondary outcomes (3)
Mean scores of the symptom questionnaires mentioned above.
Measured: Days 1 to 5.
Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.
Measured: Days 1 and 8.
Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoidal DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT00935948
- Sponsor's protocol ID
- 04497
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment
- ClinicalTrials.gov ID
- NCT00935948
- Acronym / sponsor ID
- 04497
- Conditions
- Hemorrhoidal Disease
- Keywords
- hemorrhoids, hemorrhoidal disease, water smartweed, hamamelis, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- First posted
- 9 Jul 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 aim of our study was to assess the clinical efficacy and safety of the drug Imescard compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
Detailed description
The drug Imescard compound water smartweed ointment is currently registered at the brazilian National Sanitary Surveillance Agency (ANVISA) as a topic hemorrhoidal treatment. It's composed by adrenalin, which produces vasoconstriction, benzocaine, an anesthetic, hamamelis, which is believed to have a desiccative and astringent activity, and water smartweed (Polygonum hydropiperoides), commonly used in the treatment of this condition, with, however, little or no evidence other than tradition to support its use. The aim of this study was to assess the clinical efficacy and safety of this drug in the treatment of hemorrhoidal disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.
Sixty healthy volunteers with ages between 18 to 70 years old who presented with 2nd to 4th degree hemorrhoids were enrolled after clinical and laboratory evaluation (day 0) and then randomized (day 1) to receive either the Imescard ointment after waking up, after evacuations and before bedtime, for 5 days, or placebo, with the exact same appearance and posology. At followup (day 8), patients underwent new clinical and laboratory evaluation. Main outcome was the percentage of patients with 50% improval of symptoms, assessed by a diary containing symptom questionnaires concerning every day of treatment. Secondary outcomes were mean scores of the symptom questionnaires, life quality improval assessed by WHOQOLbrief at days 1 and 8 and adverse effects evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imescard ointment | Active comparator | Drug: Imescard compound water smartweed ointment |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years old
- 2nd to 4th degree hemorrhoids clinically diagnosed
- Proper anticonception, in the case of women in fertile age
- Possibility to abstain from any other drugs (except in emergencies, in wich case the responsible party must be informed)
- Good understanding and agreement to informed consent form
Key exclusion criteria (5 listed)
- Hypersensitivity to any of the components of the drug
- Use of alcohol or drugs
- Clinical evidence of immunosupression
- Abnormalities in baseline laboratory exams
- Diagnosis of any acute disease in current activity or chronic disease uncontrolled
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 compound water smartweed ointmentAlso: Imescard, Water smartweed ointmentPatients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days. | Drug | Imescard ointment |
| PlaceboPatients in this arm received placebo, with the exact same appearance of the Imescard ointment, and were instructed to apply it at the same intervals and period. | Drug | Placebo |
Primary outcome
Improval of 50% or more in hemorrhoidal symptoms, assessed by questionnaires concerning pain, swelling, secretion and bleeding of hemorrhoids, contained in a diary that patients were instructed to fulfill daily during the treatment.
Time frame: Days 1 to 5.
3 secondary outcomes
Mean scores of the symptom questionnaires mentioned above.
Time frame: Days 1 to 5.
Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.
Time frame: Days 1 and 8.
Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
Related trials for Hemorrhoidal Disease
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Not yet recruitingPhase 2
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
Hemorrhoidal Disease
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
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 compound water smartweed ointment in people with Hemorrhoidal Disease, 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 5 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 9 Jul 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. Some participants in this study may receive a placebo. 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?
Improval of 50% or more in hemorrhoidal symptoms, assessed by questionnaires concerning pain, swelling, secretion and bleeding of hemorrhoids, contained in a diary that patients were instructed to fulfill daily during the treatment. (time frame: Days 1 to 5.). 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 9 Jul 2009.