Mesoglycan for Acute Hemorrhoidal Disease

NCT06101992 | Unknown

• 1 other identifier: SICCR23
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mesoglycan

ACTIVE COMPARATOR

According to randomization, patients will take mesoglycan mg 50 (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) 4 capsules/day for 5 days and 2 capsules/day for 35 days

Drug: Mesoglycan

Placebo

PLACEBO COMPARATOR

According to randomization, patients will take placebo (lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate) 4 capsules/day for 5 days and 2 capsules/day for 35 days

Other: Placebo

Interventions

Mesoglycan DRUG

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

Also known as: MES

Mesoglycan

Placebo OTHER

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

Also known as: PLA

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead
• Neopharmed Gentili S.p.A.: collaborator

Related Publications (1)

• Gallo G, Picciariello A, Realis Luc A, Salvatore A, Di Vittori A, Rinaldi M, Trompetto M. Use of mesoglycan in the acute phase of hemorrhoidal disease (the CHORMES study): study protocol for a double-blind, randomized controlled trial. Trials. 2024 Dec 2;25(1):807. doi: 10.1186/s13063-024-08648-y.

  PMID: 39623365 DERIVED

MeSH Terms

Conditions

Hemorrhoids

Interventions

mesoglycan

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arcangelo Picciariello, MD

  Societa Italiana di Chirurgia ColoRettale

  STUDY CHAIR

Central Study Contacts

Marcella Rinaldi, MD

CONTACT

+393382182556; marcella.rinaldi@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized double-blind controlled clinical trial

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10