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IRCT20141116019971N5 IRCT 2021-02-07 Tehran University of Medical Sciences Diltiazem Gel or Ointment, Which One is a Better Choice for Anal Fissure? Diltiazem Gel Verus Diltiazem Ointment in Alleviating the Symptoms of Chronic Anal Fissure; a Randomized Clinical Trial. 2021-01-19 anticipated 70 Complete https://irct.ir/trial/52424 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computer-generated block randomization. 3 Anal fissure. Intervention 1: Intervention group: The first group will receive topical jel diltiazem 2% produced by Sobhan daroo co. two times per day q 12 hours. Intervention 2: Control group: The second group will receive topical ointment diltiazem 2% produced by Woodland hills pharmacy two times per day q 12 h. Yes - There is a plan to make this available What will be shared: upon completion of the study, Individual participant data (anonymous) comprising age, gender, pain intensity, and vital signs will be released. When: Access to the information starts in 2021. To whom: All researchers have the possibility to access the data regardless of the research field. Conditions: There is no specific criteria for data access. Where to obtain: To request data access, please contact to Dr Ehsan Karimi. E-mail: drkarimi86@gmail.com, Phone number: 00989122493628, Address: Sina hospital, Imam Khomeini Avenue. How to obtain: Upon contact, data will be sent by email. Comments:
public Ehsan Karimialavijeh
Sina Hospital, Imam Khomeini Avenue, Hasan Abad Square
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 drkarimi86@gmail.com Tehran University of Medical Sciences scientific Ehsan Karimialavijeh
Sina Hospital, Hasan abad Square, Imam Khomeini Avenue,
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 drkarimi86@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Symptoms of anal fissure (pain, bleeding, burning, or itching) in the last six weeks. Finding one of the following signs on examination: visible sphincter fibers at the fissure base, anal papillae, sentinel piles, and indurated margins. 18 years no limit Both Past history of anal surgery Current consumption of other topical or oral medication for anal fissure. History of allergic reaction to diltiazem. History of cardiovascular problems including sick sinus syndrome, heart block, arrhythmia, bradycardia, heart failure, and cardiomyopathy. Hypotension (systolic blood pressure < 90 mmHg). History of chronic liver failure. Current consumption of antihypertensive drugs. Pregnancy and breast feeding. Failure to obtain informed consent. K60.2 Anal fissure Treatment - Drugs Treatment - Drugs Intervention group: The first group will receive topical jel diltiazem 2% produced by Sobhan daroo co. two times per day q 12 hours. Control group: The second group will receive topical ointment diltiazem 2% produced by Woodland hills pharmacy two times per day q 12 h. Pain intensity. Timepoint: Before treatment and four weeks treatment. Method of measurement: Visual analog scale. Itching. Timepoint: Before treatment and four weeks treatment. Method of measurement: Inquiring the patient about presence or absence of itching. Bleeding. Timepoint: Before treatment and four weeks treatment. Method of measurement: Inquiring the patient about presence or absence of bleeding. Side effects including hives, hypotension, vertigo, palpitation, light headedness. Timepoint: Four weeks post-treatment. Method of measurement: Inquiring the patient about presence or absence of side effects. Tehran University of Medical Sciences Approved 2020-08-15 Tehran University of Medical Sciences Tehran University of Medical Sciences, Poorsina Avenue, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)