Application of Vitamin E on Anal Fissure

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Vitamin E Acetate ointment; Drug: Glyceryl trinitrate ointment

• Registration Number: NCT03787030
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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 .

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-21
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E acetate	Vitamin E Acetate ointment	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.
Glyceryl trinitrate ointment	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.

Primary Outcome Measures

Name	Time	Method
Pain associated to anal fissure: Visual Analogic Scale	8 weeks	Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)

Secondary Outcome Measures

Name	Time	Method
Number of participants achieving the healing of the fissure	8 weeks	Healing, defined as evidence of fissure reepithelization

Trial Locations

Locations (1)

Garcilaso Clinic; 🇪🇸 Madrid, Spain