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Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade

NCT07376928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 131

Last updated 2026-01-29

No results posted yet for this study

Summary

Hemorrhoidal disease is one of the most common proctologic disease. This condition affects a large number of people in the world: the prevalence can vary from 4.4% in the general population to 36.4% in general practice \[1\]. It usually appears with symptoms and signs of bleeding, prolapse, soiling, itching, and pain. Bleeding is the most relevant and frequent symptom, reported by 56-81% of the patients; this sign is the most important reason for which most of patients are worried and they decide to be subjected to proctologic examination.

Medical and conservative management (life style changes, high-fiber diets, stool softeners, laxatives, and sitz baths are treatments chosen in hemorrhoidal disease from Goligher's I to III grade.

Hemorrhoidal disease (HD) has a significative incidence accounting for a large number of consultation per year and a large number of ambulatory or surgical treatments. Early symptoms are often treated tempirically with self prescription and OTC (over-the-counter) products with in spite of the value of different substances available.

In addition, symptoms such as tenesmus, mucus secretion or intense anal pain, if frequent and intense, significantly worsen the patient's quality of life and therefore require particular attention Phlebotonics are heterogeneous and widely investigated classes of drugs used to treat hemorrhoidal disease, with the aim to obtain strengthening of blood vessel walls, increasing venous tone, lymphatic drainage, normalizing capillary permeability, and anti-inflammatory effects.

Scientific production includes research on individual active ingredients but also on products that exploit the synergy of multiple active ingredients. Furthermore, the use of flavonoids is being analyzed both as an alternative to surgery, both in preparation and after the surgery itself.

Conditions

  • Hemorrhoidal Disease

Interventions

DRUG

Phlebotonic

Phlebotonics treatment will be used

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2025-01-28
Completion
2025-01-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376928 on ClinicalTrials.gov