HemorrhoidsCHORMESNCT06101992
Mesoglycan for Acute Hemorrhoidal Disease
A study testing Mesoglycan in people with Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Mesoglycan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Blood coagulations disorders
- Patients undergoing chemoradiation
- intake of anticoagulants
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease
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.
Read more
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
- Being tested
- Mesoglycan, Placebo
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesoglycanDrug
Also called MES
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
PlaceboOther
Also called PLA
placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Collaborators
- Neopharmed Gentili S.p.A.
- Responsible party
- Sponsor
- Investigators
- Arcangelo Picciariello, MD, Study chair, Societa Italiana di Chirurgia ColoRettale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101992
- Sponsor's protocol ID
- SICCR23
- Acronym
- CHORMES
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39623365
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT06101992
- Acronym / sponsor ID
- CHORMES / SICCR23
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Collaborators
- Neopharmed Gentili S.p.A.
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Mesoglycan | Active comparator | Drug: MesoglycanAccording 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 |
| Placebo | Placebo comparator | Other: PlaceboAccording 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Blood coagulations disorders
- Patients undergoing chemoradiation
- intake of anticoagulants
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesoglycanAlso: MESMesoglycan 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 | Drug | Mesoglycan |
| PlaceboAlso: PLAplacebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate | Other | Placebo |
Primary outcome
Symptoms relief
Time frame: 40 days
According to the validated Hemorrhoidal Disease Symptom Score (from 0: no symptoms to 20: symptoms occurring every day), score reduction will be evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39623365Gallo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arcangelo Picciariello, MD study chair
Societa Italiana di Chirurgia ColoRettale
Questions about this trial
What is this clinical trial studying?
A study testing Mesoglycan in people with Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcella Rinaldi, MD (+393382182556, marcella.rinaldi@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms relief (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.