Irritation and Anal Bleeding in Patients Affected by Hemorrhoids. (IR-AN-BLEED)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Hemorrhoids

Treatments: Drug: flavonoid-based supplements; Behavioral: standard of care; Drug: Centella Complex

Study type: Interventional

Funder types: Other

Identifiers

NCT03569930

URomLS-5

Details and patient eligibility

About

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

Full description

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.

Secondary objectives are the evaluation of the longitudinal trend in time of anal irritation measured with the VAS scale and the study of the longitudinal performance of BMI (Body Mass Index).

The patients enrolled in the protocol will be randomized into 3 groups: the control group in which the patients will be subjected to a diet rich in water and vegetable fibers, hygienic care and anal dilator according to the traditional standardized scheme. The two experimental groups will be subjected to the same standard therapeutic scheme (diet rich in water and vegetable fibers, hygienic) of the controls, in addition to which will be added to oral supplements (group "ProtFlav") and local application as an anal cream (group "ProtCent"). Of the patients in the interventional groups, half will take flavonoid-based supplements (ProtFlav) and the other half will take supplements and anal cream based on Centella asiatica (ProtCent), as better specified below. All patients will be followed for a period of 8 weeks or otherwise until recovery (disappearance of irritation and stop bleeding).

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

Standard

Experimental group

Description:

standard of care (diet rich in water and vegetable fibers, hygienic)

Treatment:

Behavioral: standard of care

ProtFlav

Experimental group

Description:

oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care

Treatment:

Drug: flavonoid-based supplements

ProtCent

Experimental group

Description:

anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care

Treatment:

Drug: Centella Complex