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Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03569930
Acronym
IR-AN-BLEED
Enrollment
105
Registered
2018-06-26
Start date
2018-05-01
Completion date
2019-05-01
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Keywords

Flavonoid-based supplements, Centella asiatica, Hemorrhoids, defecation, bleeding, pain

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).

Interventions

DRUGflavonoid-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).

DRUGCentella 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.

BEHAVIORALstandard of care

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
delta of time necessary for the disappearance of bleeding3 monthscomparative assessment of the time necessary for the disappearance of bleeding

Secondary

MeasureTime frameDescription
delta of BMI (Body Mass Index).3 monthsthe longitudinal performance of BMI (Body Mass Index).
delta of Visual Analog Scale for Pain (VAS Pain)3 monthslongitudinal 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))

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026