Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Phase 3

• Conditions: Pain; Bleeding Anal; Stings
• Interventions: Drug: Prednisolone ointment; Drug: Vitamin E ovules

• Registration Number: NCT04362384
• Lead Sponsor: Hospital General Universitario Elche

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).

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Study Start: 2020-05-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone ointment	Prednisolone ointment	Endoanal Prednisolone ointment will be prescriped during 14 days
Vitamin E ovules	Vitamin E ovules	Endoanal Vitamin E ovules will be prescriped during 14 days

Primary Outcome Measures

Name	Time	Method
% of patients with Bleeding	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)

Secondary Outcome Measures

Name	Time	Method
Anal pain assessed by Visual Analogic Scale	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)
% of patients with Stinging	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)