Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

NCT ID: NCT03569930

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-05-01

Brief 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

Detailed 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).

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard

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

Group Type: EXPERIMENTAL

standard of care

Intervention Type: BEHAVIORAL

diet rich in water and vegetable fibers, hygienic and anal dilator

ProtFlav

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

Group Type: EXPERIMENTAL

flavonoid-based supplements

Intervention Type: DRUG

Ingredients: soybean oil (glycine max), edible gelatin, rutin, borage seed oil (borago officinalis), pineapple dry extract (ananas sativus), glycerol, thickeners (mono and diglycerides of fatty acids), emulsifier (soy lecithin).

ProtCent

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

Group Type: EXPERIMENTAL

Centella Complex

Intervention Type: DRUG

The components are: Centella Asiatica, Beta-glucan, Arnica, Aloe Vera, Menthol, Devil's claw, perform actions useful to alleviate the painful symptomatology, restore the tone of the venous wall, assist the treatment of microcirculatory damage.

Interventions

flavonoid-based supplements

Ingredients: soybean oil (glycine max), edible gelatin, rutin, borage seed oil (borago officinalis), pineapple dry extract (ananas sativus), glycerol, thickeners (mono and diglycerides of fatty acids), emulsifier (soy lecithin).

Intervention Type: DRUG

Centella Complex

The components are: Centella Asiatica, Beta-glucan, Arnica, Aloe Vera, Menthol, Devil's claw, perform actions useful to alleviate the painful symptomatology, restore the tone of the venous wall, assist the treatment of microcirculatory damage.

Intervention Type: DRUG

standard of care

diet rich in water and vegetable fibers, hygienic and anal dilator

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Massimo Chiaretti

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Rome, RM, Italy

Countries

Italy

Other Identifiers

URomLS-5

Identifier Type: -

Identifier Source: org_study_id