Topical Vitamin E Ovules for the Treatment of Hemorrhoids

April 22, 2020 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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

Unknown

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Vitamin E ovules
Endoanal vitamin E ovules will be prescribed
Active Comparator: Prednisolone ointment
Endoanal Prednisolone ointment will be prescriped during 14 days
Drug: Prednisolone ointment
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

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Principal Investigator: Jaime Ruiz Tovar Polo, Garcilaso Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Garcilaso 2020/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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