Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease

Omikron Italia

Status: Completed

Conditions: Hemorrhoid Pain; Haemorrhoid Inflammation

Treatments: Device: CONAN® Proctological Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05984641

CONAN2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 and 70 years
• 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

• Known hypersensitivity to study products
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Device: CONAN® Proctological Cream

Group B

No Intervention group

Description:

No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.