A New Class IIb MD in Proctological Disorders

Inclusion criteria

• Patients of both sexes aged between 18 and 75 years.
• Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.

*Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.

Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.

Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.

Grade 4 - Haemorrhoid remains prolapsed outside of the anus.

• Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
• Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
• Willingness to participate in the study and to sign an informed consent form.

Exclusion criteria

• Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
• Patients presenting complicated haemorrhoids.
• Patients with Crohn's disease or malignancy.
• Patients presenting undiagnosed abnormal rectal bleeding.
• Patients with known or suspected rectal hypersensitivity.
• Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
• Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
• Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
• Patients pregnant or breastfeeding.
• Patients reporting past or present narcotic addiction or alcoholism.
• Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
• Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
• Patients who in the opinion of the principal Investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
• Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.