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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Unknown status

CT.gov ID

NCT03569930

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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:

the control group in which the patients will be subjected to the standard therapeutic care (diet rich in water and vegetable fibers, hygienic),
interventional group "ProtFlav": in which oral supplements (flavonoid-based supplements

ProtFlav) will be added to standard of care

interventional group "ProtCent": in which an anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids	Drug: flavonoid-based supplements Drug: Centella Complex Behavioral: standard of care	Phase 4

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard standard of care (diet rich in water and vegetable fibers, hygienic)	Behavioral: standard of care diet rich in water and vegetable fibers, hygienic and anal dilator
Experimental: ProtFlav oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care	Drug: 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).
Experimental: ProtCent anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care	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.

Arm

Intervention/Treatment

Experimental: Standard

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

Behavioral: standard of care

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

Experimental: ProtFlav

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

Drug: 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).

Experimental: ProtCent

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

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.

Outcome Measures

Primary Outcome Measures

delta of time necessary for the disappearance of bleeding [3 months]
comparative assessment of the time necessary for the disappearance of bleeding

Secondary Outcome Measures

delta of Visual Analog Scale for Pain (VAS Pain) [3 months]
longitudinal trend in time of anal irritation measured with the VAS scale for Pain (The VAS scale for pain is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best))
delta of BMI (Body Mass Index). [3 months]
the longitudinal performance of BMI (Body Mass Index).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.