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Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments

NCT03355846 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-07-13

No results posted yet for this study

Summary

Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.

Conditions

  • Acute Anal Fissure

Interventions

DRUG

Centella

after meals twice a day for 15 days

DRUG

Proctocella

after hygiene treatment for 4 weeks;

DRUG

Flavonil® cps

after meals twice a day for 15 days

DRUG

Flavonil® Cream

treatment for 4 weeks; .

DRUG

Rectalgan Mousse

for 4 weeks

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-05-01
Completion
2018-05-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355846 on ClinicalTrials.gov