- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362384
Topical Vitamin E Ovules for the Treatment of Hemorrhoids
Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with hemorrohoids grade II and III were included.
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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Grade II and III hemorrhoids
Exclusion Criteria:
- Grade I or IV hemorrhoids
- Patients with previous anal surgeries
- Patients having received previous pharmacological treatments for hemorrhoids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin E ovules
Endoanal Vitamin E ovules will be prescriped during 14 days
|
Endoanal vitamin E ovules will be prescribed
|
Active Comparator: Prednisolone ointment
Endoanal Prednisolone ointment will be prescriped during 14 days
|
Endoanal Prednisolone ointment will be prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% of patients with Bleeding
Time Frame: 14 days after beginning the treatment
|
The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination.
The variable will be measured as present (1) or absent(0)
|
14 days after beginning the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anal pain assessed by Visual Analogic Scale
Time Frame: 14 days after beginning the treatment
|
The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)
|
14 days after beginning the treatment
|
% of patients with Stinging
Time Frame: 14 days after beginning the treatment
|
The patient refers stinging sensation (patients´self-report) .
The variable will be measured as present (1) or absent(0)
|
14 days after beginning the treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jaime Ruiz Tovar Polo, Garcilaso Clinic
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Hemorrhoids
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Prednisolone
- Vitamin E
Other Study ID Numbers
- Garcilaso 2020/2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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