An interventional study of CONAN® Proctological Cream in Hemorrhoid Pain and Haemorrhoid Inflammation, sponsored by Omikron Italia S.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Omikron Italia S.r.l. · Not applicable, Interventional, and Treatment
Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.
Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 40 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Omikron Italia S.r.l. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Device: CONAN® Proctological Cream
No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
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.
Change in the symptom numerical rating scale
The primary outcome was the change in the symptom numerical rating scale (NRS) score after one month (V3) of treatment compared to the baseline in the two groups.
Time frame: 30 days
Evaluation of potential adverse events and treatment compliance
The safety of the treatment was investigated by recording and systemic and local adverse events such as systemic allergic reactions, skin sensitisation and discomfort, etc. Treatment compliance was evaluated through assessment by the investigator of the empty study treatment cream tubes returned by patients at the end of the study.
Time frame: 30 days
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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