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Reviews on Recent Clinical Trials

Eiditor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Clinical Trial

Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial

Author(s): Alessandro Sturiale*, Gaetano Gallo, Luigi Brusciano, Concetta Cacace, Danilo Cafaro, Felipe Celedon Porzio and Gabriele Naldini

Volume 15 , Issue 2 , 2020

Page: [152 - 159] Pages: 8

DOI: 10.2174/1574887115666200421110107

Price: $65

Abstract

Introduction: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group.

Materials and Methods: From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group.

Results: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded.

Conclusion: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.

Keywords: Cortisone-free cream, hemorrhoidal prolapse, hemorrhoids, Proctosoll Allevia®, safety and efficacy, randomized clinical trial.

Graphical Abstract

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