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IRCT20121031011341N10 IRCT 2018-04-16 Fasa University of Medical Sciences Efficacy of a topical formulation of Myrtus communis L. on chronic anal fissure Efficacy of a topical formulation of Myrtus communis L. for patients with chronic anal fissure 2018-04-04 anticipated 60 Complete https://irct.ir/trial/29090 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization : block Unit of randomization: individual Tools used in randomization: table of random numbers, sealed envlops, computer softwares How the random sequence was built : The group secretary, based on the number of envelopes (containing letters A and B, respectively, denotes the intervention and control group), identifies the patients for the use of the treatment.Thus, Allocation Concealment is fully observed and the treatment team as well as the statistical analyst are unaware of the allocation of treatment to patients and this process is unpredictable, Blinding description: The treatment team, as well as the statistical analyst, are unaware of the allocation of treatment to patients and this process is unpredictable. After the completion of work and statistical analysis of the data are decoded. N/A Chronic anal Fissure. Intervention 1: Topical formulation of Myrtus communis L, three times a day on anus. Intervention 2: Diltiazem, three times a day on anus. 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 further information.
public Dr.Abdolali Pakdaman
Fasa University of Medical Sciences, Ebn Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686668 +98 71 5335 0996 mehrdadpak48@gmail.com Fasa University of Medical Sciences scientific Dr. Mohammad Hashem Hashempur
Traditional Medicine Departmen Office, Fasa University of Medical Sciences, Ebn Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686668 +98 71 5335 0996 hashempur@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:the age over 18 years to maximum 70 years;The presence of symptoms of chronic anal fissure (including: bleeding, pain, or both,) for more than 6 weeks;the presence of anal fissure in physical exam;the appearance of horizontal fibers of internal anal sphincter and or sentinel anal tag or hypertrophic papilla;;written informed consent for inclusion. 18 years 70 years Both Exclusion criteria:sensitivity and allergy to Myrtus communis L. or Diltiazem or Acetaminophen ;anal or rectal surgeries during 12 weeks ago;inflammatory bowel disease;others anal disease including abscess,fistula,moderate or severe eczema around anus or mass(pile);Immunodeficiency diseases;A history of diseases that require continued consumption of analgesics;any cardio-vascular or cerebro-vascular disease;consumption of calcium channel blochers drugs in general or current use of them in threatment of fissure;history of radiotherapy to pelvic region;anal fibrosis or fixed stenosis;history of important renal ,liver,neurologic,hematologic and psychiatry diseases;history of stool incontinency;history of chronic constipation or constipation during 4 weeks ago( 2 episodes defication or less weekly with straining or dense stool passing);pregnancy and lactation;alcohol and opium addiction;inability to cooperate in completing forms(mood disorders or language problems) K60.1 Chronic anal Fissure Treatment - Drugs Placebo Topical formulation of Myrtus communis L, three times a day on anus Diltiazem, three times a day on anus Discomfort during defication. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale. Anal pain after defication. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale. Anal bleeding. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale. Patient's Global Impression of Improvement (PGI-I). Timepoint: At the beginning of intervention and every two weeks in person. Method of measurement: Visual Analogue Scale. Reepithelialization. Timepoint: At the beginning of intervention and every two weeks in person. Method of measurement: Physical exam. Comparison of possible complications of topical formulation of Myrtus communis L.with Diltiazem. Timepoint: Every week by phone call. Method of measurement: Question by check list. Comparison of topical formulation of Myrtus communis L.with Diltiazem at amount of acetaminophen consumption. Timepoint: Every week by phone call. Method of measurement: Based on counting pills. Fasa University of Medical Sciences Approved 2016-12-27 Ethics Comimtte of Fasa University of Medical Sciences Vice Chancellor of Research and Technolog, Fasa University of Medical Sciences, Ebn Sina square, Fasa Fasa Fars Iran (Islamic Republic of)