Application of Vitamin E on Anal Fissure

Overview

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 Title of Study: “Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 28, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Pain associated to anal fissure: Visual Analogic Scale
    • Time Frame: 8 weeks
    • Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 to 100mm

Secondary Measures

  • Healing
    • Time Frame: 8 weeks
    • Healing, defined as evidence of fissure reepithelization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Elche
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery – Hospital General Universitario Elche
  • Overall Official(s)
    • Damian Garcia, Study Chair, Hospital Rey Juan Carlos
  • Overall Contact(s)
    • Jaime Ruiz-Tovar, (0034)630534808, jruiztovar@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.