Application of Vitamin E on Anal Fissure

Pain Clinical Trial

Official title:

Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787030
• Other study ID #: Garcia 2018-12
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2020
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fissure in Ano
• Pain

Intervention

Drug:
• Vitamin E Acetate ointment
Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
• Glyceryl trinitrate ointment
Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Locations

Country	Name	City	State
Spain	Garcilaso Clinic	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain associated to anal fissure: Visual Analogic Scale	Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)	8 weeks
Secondary	Number of participants achieving the healing of the fissure	Healing, defined as evidence of fissure reepithelization	8 weeks