Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2024-01-01
2024-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mesoglycan
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
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
Placebo
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
Placebo
placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate
Interventions
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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
Placebo
placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients of childbearing age with a negative pregnancy test
* Patients able to understand informed consent
* Signed Informed Consent.
Exclusion Criteria
* Patients undergoing chemoradiation
* intake of anticoagulants
* pregnancy
18 Years
75 Years
ALL
No
Sponsors
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Neopharmed Gentili S.p.A.
INDUSTRY
Societa Italiana di Chirurgia ColoRettale
NETWORK
Responsible Party
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Principal Investigators
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Arcangelo Picciariello, MD
Role: STUDY_CHAIR
Societa Italiana di Chirurgia ColoRettale
Central Contacts
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References
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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.
Other Identifiers
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SICCR23
Identifier Type: -
Identifier Source: org_study_id
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