Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

Hemorrhoids Clinical Trial

— IR-AN-BLEED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03569930
• Other study ID #: URomLS-5
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: May 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhoids

Intervention

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).
• 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.

Behavioral:
• standard of care
diet rich in water and vegetable fibers, hygienic and anal dilator

Locations

Country	Name	City	State
Italy	Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delta of time necessary for the disappearance of bleeding	comparative assessment of the time necessary for the disappearance of bleeding	3 months
Secondary	delta of Visual Analog Scale for Pain (VAS Pain)	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))	3 months
Secondary	delta of BMI (Body Mass Index).	the longitudinal performance of BMI (Body Mass Index).	3 months