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Application of Vitamin E on Anal Fissure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787030
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, 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 .


Condition or disease Intervention/treatment Phase
Pain Drug: Vitamin E Acetate ointment Drug: Glyceryl trinitrate ointment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
Primary Purpose: Treatment
Official Title: Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of participants achieving the healing of the fissure [ Time Frame: 8 weeks ]
    Healing, defined as evidence of fissure reepithelization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787030


Locations
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Spain
Garcilaso Clinic
Madrid, Spain, 28010
Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Carolina Llavero Garcilaso Clinic
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03787030    
Other Study ID Numbers: Garcia 2018-12
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vitamin E
Tocopherols
alpha-Tocopherol
Nitroglycerin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents