Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Pain Clinical Trial

Official title:

Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04362384
• Other study ID #: Garcilaso 2020/2
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2020
• Source: Hospital General Universitario Elche
• Contact: Jaime Ruiz-Tovar
• Phone: 630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Anal
• Hemorrhoids
• Pain
• Stings

Intervention

Drug:
• Vitamin E ovules
Endoanal vitamin E ovules will be prescribed
• Prednisolone ointment
Endoanal Prednisolone ointment will be prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with Bleeding	The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0)	14 days after beginning the treatment
Secondary	Anal pain assessed by Visual Analogic Scale	The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)	14 days after beginning the treatment
Secondary	% of patients with Stinging	The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)	14 days after beginning the treatment