NCT06101992

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Societa Italiana di Chirurgia ColoRettale · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Mesoglycan	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
OTHER	Placebo	placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2023-10-26
• Last updated: 2023-10-31