drugset / Trial / NCT03569930

Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

NCT03569930 ↗

Phase 4 Unknown 105 enrolled University of Roma La Sapienza
RandomizedParallel-groupSingle-blindTreatment

Summary

Haemorrhoidal disease is an increasingly frequent benign condition, able to negatively affect the quality of working and relationship life in affected individuals.The primary objective of the study is the comparative assessment of the time necessary for the disappearance of bleeding comparatively in the three different therapies (controls, ProtFlav and ProtCent) to identify, if any, the most effective treatment, in terms of time reduction for the disappearance of bleeding in subjects affected by haemorrhoidal disease. Patients enrolled will be randomized into 3 groups: 1. the control group in which the patients will be subjected to the standard therapeutic care (diet rich in water and vegetable fibers, hygienic), 2. interventional group "ProtFlav": in which oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care 3. interventional group "ProtCent": in which an anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care

Timeline

Start
2018-05-01
Primary completion
2018-12-01
Completion
2019-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Centella Complex Unknown — Topical
Subject flavonoid-based supplements Unknown — Oral

Indications