Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.

NCT03569930 | Unknown Phase 4 DMC

• 1 other identifier: URomLS-5
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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. 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. 2.interventional group "ProtFlav": in which oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care
3. 3.interventional group "ProtCent": in which an anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care

Conditions

Hemorrhoids

Keywords

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

Outcome Measures

Primary Outcomes (1)

• delta of time necessary for the disappearance of bleeding

  comparative assessment of the time necessary for the disappearance of bleeding

  3 months

Secondary Outcomes (2)

• delta of Visual Analog Scale for Pain (VAS Pain)

  3 months

• delta of BMI (Body Mass Index).

  3 months

Study Arms (3)

Standard

EXPERIMENTAL

standard of care (diet rich in water and vegetable fibers, hygienic)

Behavioral: standard of care

ProtFlav

EXPERIMENTAL

oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care

Drug: flavonoid-based supplements

ProtCent

EXPERIMENTAL

anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care

Drug: Centella Complex

Interventions

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).

ProtFlav

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.

ProtCent

standard of care BEHAVIORAL

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

Standard

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female affected by acute haemorrhoidal disease
• Collaborating patients, able to understand

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Rome, RM, 00161, Italy

Location

MeSH Terms

Conditions

Hemorrhoids; Hemorrhage; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 26, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)