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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Experimental | standard of care (diet rich in water and vegetable fibers, hygienic) |
|
| ProtFlav | Experimental | oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care |
|
| ProtCent | Experimental | anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flavonoid-based supplements | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza" | Rome | RM | 00161 | Italy |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D006470 | Hemorrhage |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Centella Complex | 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. |
|
| standard of care | Behavioral | diet rich in water and vegetable fibers, hygienic and anal dilator |
|
| delta of BMI (Body Mass Index). | the longitudinal performance of BMI (Body Mass Index). | 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |