Mesoglycan for Acute Hemorrhoidal Disease

Hemorrhoids Clinical Trial

— CHORMES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101992
• Other study ID #: SICCR23
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Marcella Rinaldi, MD
• Phone: +393382182556
• Email: marcella.rinaldi[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale	Neopharmed Gentili S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms relief	According to the validated Hemorrhoidal Disease Symptom Score (from 0: no symptoms to 20: symptoms occurring every day), score reduction will be evaluated	40 days