drugset / Trial / NCT03355846
Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
Publications
- Background Kim DW, Chi YS, Son KH, Chang HW, Kim JS, Kang SS, Kim HP. Effects of sophoraflavanone G, a prenylated flavonoid from Sophora flavescens, on cyclooxygenase-2 and in vivo inflammatory response. Arch Pharm Res. 2002 Jun;25(3):329-35. doi: 10.1007/BF02976635.
- Background Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS. Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study. Curr Med Res Opin. 2001;17(4):256-61.
- Background Mullen W, McGinn J, Lean ME, MacLean MR, Gardner P, Duthie GG, Yokota T, Crozier A. Ellagitannins, flavonoids, and other phenolics in red raspberries and their contribution to antioxidant capacity and vasorelaxation properties. J Agric Food Chem. 2002 Aug 28;50(18):5191-6. doi: 10.1021/jf020140n.
- Background Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002 May-Jun;53(3):245-56. doi: 10.1177/000331970205300301.
- Background Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000 Jul;87(7):868-72. doi: 10.1046/j.1365-2168.2000.01448.x.
- Results Chiaretti M, Fegatelli DA, Ceccarelli G, Carru GA, Pappalardo G, Chiaretti AI. Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial. Ann Ital Chir. 2018;89:330-336.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Centella | Unknown | 60 mg | Oral |
| Subject | Flavonil | Unknown | 300 mg | Oral |
| Subject | Proctocella | Unknown | — | Topical |