Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease
NCT ID: NCT05984641
Last Updated: 2024-04-03
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-03-01
2022-09-30
Brief Summary
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Detailed Description
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Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
CONAN® Proctological Cream
The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
Group B
No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
No interventions assigned to this group
Interventions
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CONAN® Proctological Cream
The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
Eligibility Criteria
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Inclusion Criteria
* Hemorrhoidal pathology, anal fissures and anitis
* NRS score ≥ 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body)
Exclusion Criteria
* Proctitis
* Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
* Surgical treatments undergone less than a year after inclusion
* Pregnancy, breastfeeding
18 Years
70 Years
ALL
No
Sponsors
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Omikron Italia S.r.l.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicola Di Lorenzo, Medicine
Role: PRINCIPAL_INVESTIGATOR
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
Gabriella Giarratano, Medicine
Role: STUDY_CHAIR
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
Locations
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Policlinico Tor Vergata Foundation (PTV)
Rome, , Italy
Countries
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Other Identifiers
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CONAN2019
Identifier Type: -
Identifier Source: org_study_id
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