Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05984641
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-08-02
Brief Title:
Efficacy and Safety of CONAN Proctological Cream for Treatment of Haemorrhoidal Disease
Sponsor:
Omikron Italia Srl
Organization:
Omikron Italia Srl
Study Overview
Official Title:
Efficacy and Safety of CONAN Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None