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IRCT20230607058408N1 IRCT 2023-06-29 Gonabad University of Medical Sciences Investigating the effect of topical diltiazem and botulinum toxin injection in the treatment of chronic anal fissure Comparison of the effectiveness, recurrence rate and side effects of two therapeutic methods of Botulinum toxin injection and topical Diltiazem in the treatment of patients with chronic anal fissures 2023-07-23 anticipated 60 Complete https://irct.ir/trial/70871 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: How to assign people to two intervention groups: with the available sampling method, a number of patients with chronic anal fissure referring to the surgery clinic are selected and after receiving the necessary information about how to perform both treatment, They consciously choose a group. 2 Chronic anal fissure. Intervention 1: Intervention group one: Injection of 100 units of Botox in four divided doses of 25 units at 3, 6, 9 and 12 hours in the internal anal sphincter. Intervention 2: Intervention group two: Administration of 2% diltiazem ointment topically around the anus three times a day (every 8 hours) for one week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fahime Mehrabi
Gonabad university of medical sciences , DR Mahdizade Blvd
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 Fahimemehrabi99@gmail.com Gonabad University of Medical Sciences scientific Fahime Mehrabi
Gonabad university of medical sciences , DR Mahdizade Blvd
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 Fahimemehrabi99@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) People with chronic anal fissure between the ages of 18 and 80 18 years 80 years Both Immune deficiency (using corticosteroids for more than 3 months, patients receiving transplants, receiving chemotherapy or radiotherapy, HIV positive patients with CD4 less than 200) Inflammatory bowel diseases Tuberculosis Recurrent anal fissure and complicated anal fissure (stenosis, abscess, fistula or hemorrhoids) Colon malignancy Pregnancy K60.1 Chronic anal fissure Treatment - Drugs Treatment - Drugs Intervention group one: Injection of 100 units of Botox in four divided doses of 25 units at 3, 6, 9 and 12 hours in the internal anal sphincter Intervention group two: Administration of 2% diltiazem ointment topically around the anus three times a day (every 8 hours) for one week. Chronic anal fissure. Timepoint: Examination of anal fissure at the beginning of the study and 14 days later and at the end of the first, second, fourth and sixth months after the intervention. Method of measurement: Checklist and questionnaire. Gonabad University of Medical Sciences Approved 2023-02-21 Ethics committee of gonabad university of mwdical sciences Gonabad university of medical sciences , DR Mahdizade Blvd Gonabad Razavi Khorasan Iran (Islamic Republic of)