Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Bleeding Anal; Stings; Pain

Treatments: Drug: Prednisolone ointment; Drug: Vitamin E ovules

Study type: Interventional

Funder types: Other

Identifiers

NCT04362384

Garcilaso 2020/2

Details and patient eligibility

About

Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:

• Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
• Control group: Patients will receive a treatment with corticoid ointment, with endoanal application

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

Full description

Patients with hemorrohoids grade II and III were included.

Patients were randomized into 2 groups:

• Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
• Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade II and III hemorrhoids

Exclusion criteria

• Grade I or IV hemorrhoids
• Patients with previous anal surgeries
• Patients having received previous pharmacological treatments for hemorrhoids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Vitamin E ovules

Experimental group

Description:

Endoanal Vitamin E ovules will be prescriped during 14 days

Treatment:

Drug: Vitamin E ovules

Prednisolone ointment

Active Comparator group

Description:

Endoanal Prednisolone ointment will be prescriped during 14 days

Treatment:

Drug: Prednisolone ointment

Sponsor of this trial

Lead Sponsor

Hospital General Universitario Elche