Irritation and Anal Bleeding in Patients Affected by Hemorrhoids. (IR-AN-BLEED)

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

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

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids
• Intervention / Treatment: Behavioral: standard of care; Drug: flavonoid-based supplements; Drug: Centella Complex

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).

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00161
      • Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: June 23, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; bleeding; Hemorrhoids; Centella asiatica; defecation; Flavonoid-based supplements
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhage; Hemorrhoids
• Other Study ID Numbers: URomLS-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No