A Phase 4 interventional study of Centella and Proctocella in Acute Anal Fissure, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment
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:
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.
84 studies on the registry are indexed under Fissure in Ano; 16 are open to participants now.
This study's enrollment of 99 is close to the median of 99 across 65 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Centella® Complex 1 cps 60 mg per os
Drug: Centella
Proctocella® Complex cream to be applied in anal area and anal canal
Drug: Proctocella
Flavonil® 1 cps 300 mg per os
Drug: Flavonil® cps
Flavonil® Cream Cream to be applied in anal region and anal canal
Drug: Flavonil® Cream
Rectalgan Mousse cleansing cleanser for anal and perineal region
Drug: Rectalgan Mousse
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
time for the disappearance of pain
time for the disappearance of pain in course of treatment
Time frame: 1 month
time for the disappearance of bleeding
time for the disappearance of bleeding in course of treatment
Time frame: 1 month
Plan to share: No
Ran from May 2018 to primary completion in May 2018, 0 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Centella asiatica
University of Roma La Sapienza →