Efficacy and Safety Evaluation of the Imescard Compound Water Smartweed Ointment
Phase 3 Clinical Trial - Efficacy and Safety Evaluation of the Drug Imescard Compound Water Smartweed, Adrenalin and Hamamelis Ointment
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 8, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedJuly 9, 2009
July 1, 2009
1.1 years
July 8, 2009
July 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Days 1 to 5.
Secondary Outcomes (3)
Mean scores of the symptom questionnaires mentioned above.
Days 1 to 5.
Life quality was assessed through the questionnaire WHOQOLbrief, at baseline and followup.
Days 1 and 8.
Adverse effects were assessed through a specific field in the diary and at followup during clinical evaluation.
Day 8
Study Arms (2)
Imescard ointment
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.
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.
Eligibility Criteria
You may qualify if:
- Age between 18 and 70 years old
- nd 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 8, 2009
First Posted
July 9, 2009
Study Start
April 1, 2008
Primary Completion
May 1, 2009
Last Updated
July 9, 2009
Record last verified: 2009-07