Application of Vitamin E on Anal Fissure

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Vitamin E Acetate ointment; Drug: Glyceryl trinitrate ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03787030

Garcia 2018-12

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Vitamin E acetate

Experimental group

Description:

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.

Treatment:

Drug: Vitamin E Acetate ointment

Glyceryl trinitrate ointment

Active Comparator group

Description:

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.

Treatment:

Drug: Glyceryl trinitrate ointment