CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 99 enrolled
Drug / intervention
Centella +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03355846
NCT03355846Phase 4Completed

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

University of Roma La Sapienza·interventional·Posted Nov 28, 2017·Updated Jul 13, 2018

In Brief

A Phase 4 clinical trial evaluating Centella, Proctocella, and 3 other interventions for Acute Anal Fissure. Completed, enrolled 99 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartMay 1, 2018
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 8.6 years ago

Interventions

Centelladrug

after meals twice a day for 15 days

Proctocelladrug

after hygiene treatment for 4 weeks;

Flavonil® cpsdrug

after meals twice a day for 15 days

Flavonil® Creamdrug

treatment for 4 weeks; .

Rectalgan Moussedrug

for 4 weeks