Irritation and Anal Bleeding in Patients Affected by Hemorrhoids. (NCT03569930) | Clinical Trial Compass
UnknownPhase 4
Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.
Italy105 participantsStarted 2018-05-01
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
delta of time necessary for the disappearance of bleeding