Haemorrhoid Inflammation, Hemorrhoid Pain
Conditions
Keywords
Haemorrhoids; anal fissures; controlled clinical trial.
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.
Interventions
DEVICECONAN® 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.
Sponsors
Omikron Italia S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the symptom numerical rating scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of potential adverse events and treatment compliance | 30 days | 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. |
Countries
Italy
Outcome results
None listed