Clinical trial NCT03569930: Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.
Official title: Irritation and Anal Bleeding in Patients Affected by Hemorrhoids: Comparative Evaluation of Three Different Treatments.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemorrhoids
Keywords: Flavonoid-based supplements
Centella asiatica
Hemorrhoids
defecation
bleeding
pain
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: delta of time necessary for the disappearance of bleeding
timeFrame: 3 months
Secondary outcomes:
measure: delta of Visual Analog Scale for Pain (VAS Pain)
timeFrame: 3 months
measure: delta of BMI (Body Mass Index).
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"
state: RM
Study officials:
References: