Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

Irritation and Anal Bleeding in Patients Affected by Hemorrhoids: Comparative Evaluation of Three Different Treatments.

Sponsors

Lead Sponsor: University of Roma La Sapienza

Source University of Roma La Sapienza
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).

Overall Status Unknown status
Start Date 2018-05-01
Completion Date 2019-05-01
Primary Completion Date 2018-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
delta of time necessary for the disappearance of bleeding 3 months
Secondary Outcome
Measure Time Frame
delta of Visual Analog Scale for Pain (VAS Pain) 3 months
delta of BMI (Body Mass Index). 3 months
Enrollment 105
Condition
Intervention

Intervention Type: Drug

Intervention Name: flavonoid-based supplements

Description: 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).

Arm Group Label: ProtFlav

Intervention Type: Drug

Intervention Name: Centella Complex

Description: 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.

Arm Group Label: ProtCent

Intervention Type: Behavioral

Intervention Name: standard of care

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

Arm Group Label: Standard

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Location
Facility: Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"
Location Countries

Italy

Verification Date

2018-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Roma La Sapienza

Investigator Full Name: Massimo Chiaretti

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Standard

Type: Experimental

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

Label: ProtFlav

Type: Experimental

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

Label: ProtCent

Type: Experimental

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

Acronym IR-AN-BLEED
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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