Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza

Criteria

Inclusion Criteria:

• Male and female affected by acute haemorrhoidal disease

• Collaborating patients, able to understand

Exclusion Criteria:

• Women who are pregnant or have been breastfeeding;

• Previous colorectal surgery;

• Anal stenosis;

• Treatment (topical or systemic) with decongestants, diuretics, steroidal anti-inflammatory drugs or NSAIDs, antipyretics, antibiotics or antivirals for other reasons;

• Psychiatric and / or toxic employees;

• Age in completed years, less than 18 and over 85;

• If the patient's personal clinical record does not have at least two controls, it is excluded from the clinical study;

• Refusal to participate in the study.