Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
Condition: Acute Anal Fissure
MeSH terms: Fissure in Ano; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal
      spontaneously and that some of the commonly used commercial products in clinical practice
      would seem to be useful, the rationale of the comparative study is to try to identify, in
      compliance with the protocol of Helsinki (2013), the most effective short-term treatment for
      the disappearance of pain in defecation and cessation of bleeding, shortening the duration of
      the healing process and favoring the patient's rapid return to his / her activity, respect
      for patient safety.
    

Detailed description: 
      Starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that
      some of the commonly used commercial products in clinical practice would seem to be useful,
      the rationale of the comparative study is to try to identify, in compliance with the protocol
      of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in
      defecation and cessation of bleeding, shortening the duration of the healing process and
      favoring the patient's rapid return to his / her activity, respect for patient safety.

      The comparative study will be conducted by comparing the following products:

        -  Centella® Complex 1 cps 60 mg per os after meals twice a day for 15 days;

        -  Proctocella® Complex cream to be applied in anal area and anal canal after hygiene
           treatment for 4 weeks;

        -  Flavonil® 1 cps 300 mg per os after meals twice a day for 15 days;

        -  Flavonil® Cream Cream to be applied in anal region and anal canal after hygiene
           treatment for 4 weeks;

        -  Rectalgan Mousse cleansing cleanser for anal and perineal region for 4 weeks.

      Our approach attempts to blend, based on the evidence of the most recent scientific
      literature, the experience of decades of colonproctologic clinical practice that has a
      predominantly surgical approach, with the clinical evidence of the Science of Nutrition which
      has a conservative vision in the treatment of ailments and constipation, a predisposing
      factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. The
      control group will receive the traditional basic treatment consisting in the application of
      lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and
      diet. The two groups with which they will be compared for the results will receive, in
      addition to the foregoing (for controls), or Flavonoids (ProtFlav) or Asian Centella Extract
      (ProtCent), in the form of local mouth and cream tablets to be applied at the perianal level
      and possibly in the anal canal with gloved finger, containing the same active principles also
      administered by mouth.
    

Intervention name(s): Centella; Proctocella; Flavonil® cps; Flavonil® Cream; Rectalgan Mousse
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): after meals twice a day for 15 days; after hygiene treatment for 4 weeks;; after meals twice a day for 15 days; treatment for 4 weeks;
.; for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Anal Fissure; local therapy; pain; defecation; bleeding