Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

Study Overview
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Brief Summary
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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

Detailed Description
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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).

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

Conditions
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Hemorrhoids

Intervention / Treatment
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* Drug: flavonoid-based supplements
* Drug: Centella Complex
* Behavioral: standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delta of time necessary for the disappearance of bleeding | comparative assessment of the time necessary for the disappearance of bleeding | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| delta of BMI (Body Mass Index). | the longitudinal performance of BMI (Body Mass Index). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavonoid-based supplements, Centella asiatica, Hemorrhoids, defecation, bleeding, pain