Topical Vitamin E Ovules for the Treatment of Hemorrhoids
Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2020
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedApril 24, 2020
April 1, 2020
6 months
April 19, 2020
April 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
% of patients with Bleeding
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 Outcomes (2)
Anal pain assessed by Visual Analogic Scale
14 days after beginning the treatment
% of patients with Stinging
14 days after beginning the treatment
Study Arms (2)
Vitamin E ovules
EXPERIMENTALEndoanal Vitamin E ovules will be prescriped during 14 days
Prednisolone ointment
ACTIVE COMPARATOREndoanal Prednisolone ointment will be prescriped during 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Grade II and III hemorrhoids
You may not qualify if:
- Grade I or IV hemorrhoids
- Patients with previous anal surgeries
- Patients having received previous pharmacological treatments for hemorrhoids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz Tovar Polo
Garcilaso Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Symptoms will be assessed by a nurse blinded to the prescribed treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
April 19, 2020
First Posted
April 24, 2020
Study Start
May 1, 2020
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04