Trials Sponsors Conditions Drugs Pricing

Conditions

Haemorrhoid Inflammation Hemorrhoid Pain

Keywords

Haemorrhoids; anal fissures; controlled clinical trial.

Outcome Measures

Primary Outcomes (1)

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.
30 days

Secondary Outcomes (1)

Evaluation of potential adverse events and treatment compliance
30 days

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

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

Interventions

CONAN® Proctological CreamDevice

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.

Group A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged between 18 and 70 years
Hemorrhoidal pathology, anal fissures and anitis

Sponsors & Collaborators

Omikron Italia S.r.l.
Industrylead

Study Sites (1)

Policlinico Tor Vergata Foundation (PTV)

Rome, 00133, Italy

MeSH Terms

Conditions

HemorrhoidsFissure in Ano

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesAnus Diseases

Study Officials

Nicola Di Lorenzo, Medicine
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
PRINCIPAL INVESTIGATOR
Gabriella Giarratano, Medicine
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
STUDY CHAIR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 9, 2023

Study Start

March 1, 2022

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations