Application of Vitamin E on Anal Fissure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2019-02-28

Brief Summary

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Patients were randomized into 2 groups:

* Vitamin E: Vitamin E ointment will be applied during 8 weeks
* Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks

Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

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Detailed Description

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Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Healing rate of chronic anal fissure was investigated.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain

Study Groups

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Vitamin E acetate

Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Group Type EXPERIMENTAL

Vitamin E Acetate ointment

Intervention Type DRUG

Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.

Glyceryl trinitrate ointment

Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Group Type ACTIVE_COMPARATOR

Glyceryl trinitrate ointment

Intervention Type DRUG

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Interventions

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Vitamin E Acetate ointment

Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.

Intervention Type DRUG

Glyceryl trinitrate ointment

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of chronic anal fissure

Exclusion Criteria

* patients with associated anal pathologies
* intestinal inflammation disorders
* immunosuppression
* fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
* patients with a history of headaches, heart disease, or intolerance to nitrates
* pregnant or lactating women
* patients with closed angle glaucoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No