Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-31
First Post:
2023-10-20
Brief Title:
Mesoglycan for Acute Hemorrhoidal Disease
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Organization:
Societa Italiana di Chirurgia ColoRettale
Study Overview
Official Title:
Randomized Double-blind Controlled Clinical Trial the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
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 44 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 475 dermatan sulphate 355 chondroitin sulfate 85 and slow heparin 85
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 confirmevaluate 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 475 dermatan sulphate 355 chondroitin sulfate 85 and slow heparin 85
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 confirmevaluate 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:
None
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?:
None