Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in the symptom numerical rating scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in the symptom numerical rating scale
Time Frame: 30 days
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.
Secondary Outcomes
- Evaluation of potential adverse events and treatment compliance(30 days)