Trials / Completed
CompletedNCT03787030
Application of Vitamin E on Anal Fissure
Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Hospital General Universitario Elche · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 .
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
- First posted
- 2018-12-26
- Last updated
- 2020-04-22
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03787030. Inclusion in this directory is not an endorsement.