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Mesoglycan for Acute Hemorrhoidal Disease

Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06101992
Acronym
CHORMES
Enrollment
50
Registered
2023-10-26
Start date
2024-01-01
Completion date
2024-09-01
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Brief summary

Hemorrhoidal disease (HD) is the most common proctological disease with a prevalence rate that can reach approximately 4.4% of the population, with a particular peak in individuals aged between 45 and 65 years. The most common presentation of HD is painless rectal bleeding occurring during or immediately after defecation. Pain is rare in case of uncomplicated HD and may be present in case of external hemorrhoidal thrombosis. The decision-making to treat Hemorrhoidal thrombosis usually depends on the timing of the onset of symptoms, with the surgical treatment favored if the onset of symptoms occurs within 72 hours. Mesoglycan, a natural preparation of glycosaminoglycans (GAGs), is a polysaccharide complex rich in sulfur radicals. It is composed of heparan sulphate (47.5%), dermatan sulphate (35.5%), chondroitin sulfate (8.5%) and slow heparin (8.5%). Mesoglycan exerts antithrombotic activity (activation of antithrombin III and heparin cofactor II) and profibrinolytic (stimulation of the activator tissue plasminogen) decreasing plasma concentrations of fibrinogen without affecting the prothrombin time, the time of partial thromboplastin or the remaining coagulation parameters. The rationale of this double-blind randomized controlled clinical trial is to confirm/evaluate the efficacy and safety of mesoglycan versus placebo in reducing the symptoms of hemorrhoidal disease and their impact on quality of life.

Interventions

Mesoglycan capsules 50 mg are composed by heparan sulphate 47.5%, dermathan sulphate 35.5%, chondroitin sulfate 8.5%,slow heparin 8.5%, excipients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine

OTHERPlacebo

placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate

Sponsors

Neopharmed Gentili S.p.A.
CollaboratorINDUSTRY
Societa Italiana di Chirurgia ColoRettale
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Randomized double-blind controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of grade I-III hemorrhoidal disease classified according to Goligher classification or diagnosis of external hemorrhoid thrombosis * Female patients of childbearing age with a negative pregnancy test * Patients able to understand informed consent * Signed Informed Consent.

Exclusion criteria

* Blood coagulations disorders * Patients undergoing chemoradiation * intake of anticoagulants * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Symptoms relief40 daysAccording to the validated Hemorrhoidal Disease Symptom Score (from 0: no symptoms to 20: symptoms occurring every day), score reduction will be evaluated

Contacts

Primary ContactMarcella Rinaldi, MD
marcella.rinaldi@uniba.it+393382182556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026