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Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Primary Purpose

Bleeding Anal, Pain, Stings

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Vitamin E ovules

Prednisolone ointment

About this trial

This is an interventional treatment trial for Bleeding Anal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin E ovules

Prednisolone ointment

Arm Description

Endoanal Vitamin E ovules will be prescriped during 14 days

Endoanal Prednisolone ointment will be prescriped during 14 days

Outcomes

Primary Outcome Measures

% 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)

Secondary Outcome Measures

Anal pain assessed by Visual Analogic Scale

The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)

% of patients with Stinging

The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)

Full Information

NCT ID

NCT04362384

First Posted

April 19, 2020

Last Updated

April 22, 2020

Sponsor

Hospital General Universitario Elche

1. Study Identification

Unique Protocol Identification Number

NCT04362384

Brief Title

Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Official Title

Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bleeding Anal, Pain, Stings

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Symptoms will be assessed by a nurse blinded to the prescribed treatment

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin E ovules

Arm Type

Experimental

Arm Description

Endoanal Vitamin E ovules will be prescriped during 14 days

Arm Title

Prednisolone ointment

Arm Type

Active Comparator

Arm Description

Endoanal Prednisolone ointment will be prescriped during 14 days

Intervention Type

Drug

Intervention Name(s)

Vitamin E ovules

Intervention Description

Endoanal vitamin E ovules will be prescribed

Intervention Type

Drug

Intervention Name(s)

Prednisolone ointment

Intervention Description

Endoanal Prednisolone ointment will be prescribed

Primary Outcome Measure Information:

Title

% of patients with Bleeding

Description

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)

Time Frame

14 days after beginning the treatment

Secondary Outcome Measure Information:

Title

Anal pain assessed by Visual Analogic Scale

Description

The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)

Time Frame

14 days after beginning the treatment

Title

% of patients with Stinging

Description

The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)

Time Frame

14 days after beginning the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jaime Ruiz-Tovar

Phone

630534808

jruiztovar@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Carolina LLavero Garrido

Phone

649593020

carolinallavero@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaime Ruiz Tovar Polo

Organizational Affiliation

Garcilaso Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Topical Vitamin E Ovules for the Treatment of Hemorrhoids

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