Topical Vitamin E Ovules for the Treatment of Hemorrhoids
NCT ID: NCT04362384
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2020-05-01
2020-10-30
Brief Summary
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* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
* Control group: Patients will receive a treatment with corticoid ointment, with endoanal application
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
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Detailed Description
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Patients were randomized into 2 groups:
* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
* Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vitamin E ovules
Endoanal Vitamin E ovules will be prescriped during 14 days
Vitamin E ovules
Endoanal vitamin E ovules will be prescribed
Prednisolone ointment
Endoanal Prednisolone ointment will be prescriped during 14 days
Prednisolone ointment
Endoanal Prednisolone ointment will be prescribed
Interventions
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Vitamin E ovules
Endoanal vitamin E ovules will be prescribed
Prednisolone ointment
Endoanal Prednisolone ointment will be prescribed
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with previous anal surgeries
* Patients having received previous pharmacological treatments for hemorrhoids
18 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Principal Investigators
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Jaime Ruiz Tovar Polo
Role: PRINCIPAL_INVESTIGATOR
Garcilaso Clinic
Central Contacts
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Other Identifiers
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Garcilaso 2020/2
Identifier Type: -
Identifier Source: org_study_id
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