Acute Anal Fissure Clinical Trial
Official title:
Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04828889 -
Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
|
N/A |