Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-01 @ 10:44 PM
Study NCT ID:
NCT06101992
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesoglycan for Acute Hemorrhoidal Disease
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Organization:
Study Overview
Official Title:
Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHORMES
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: