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

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ClinicalTrials.gov Identifier: NCT03569930
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Massimo Chiaretti, University of Roma La Sapienza

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

Condition or disease Intervention/treatment Phase
Hemorrhoids Drug: flavonoid-based supplements Drug: Centella Complex Behavioral: standard of care Phase 4

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  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Irritation and Anal Bleeding in Patients Affected by Hemorrhoids: Comparative Evaluation of Three Different Treatments.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemorrhoids

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.




Primary Outcome Measures :
  1. delta of time necessary for the disappearance of bleeding [ Time Frame: 3 months ]
    comparative assessment of the time necessary for the disappearance of bleeding


Secondary Outcome Measures :
  1. delta of Visual Analog Scale for Pain (VAS Pain) [ Time Frame: 3 months ]
    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))

  2. delta of BMI (Body Mass Index). [ Time Frame: 3 months ]
    the longitudinal performance of BMI (Body Mass Index).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569930


Locations
Italy
Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"
Rome, RM, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza

Responsible Party: Massimo Chiaretti, Clinical Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03569930     History of Changes
Other Study ID Numbers: URomLS-5
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massimo Chiaretti, University of Roma La Sapienza:
Flavonoid-based supplements
Centella asiatica
Hemorrhoids
defecation
bleeding
pain

Additional relevant MeSH terms:
Hemorrhage
Hemorrhoids
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases