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OpenTrials
Completed

NCT Number: NCT03787030

Application of Vitamin E on Anal Fissure

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Garcilaso Clinic

Madrid, 28010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E Acetate ointment

Drug

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

Glyceryl trinitrate ointment

Drug

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

Primary outcomes

  1. 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 (absence of pain) to 100mm (unbearable pain)

Secondary outcomes

  1. Number of participants achieving the healing of the fissure

    Time frame: 8 weeks

    Healing, defined as evidence of fissure reepithelization

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2018
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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