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IRCT20210717051915N1 IRCT 2021-07-31 Esfahan University of Medical Sciences Evaluation of the effect of Glycerin suppository on anal fissure healing Evaluation of the effect of Glycerin suppository application in patients with Chronic anal fissure 2021-09-23 anticipated 120 Complete https://irct.ir/trial/57588 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with eligibility; After obtaining informed consent, are divided into two groups (control and intervention) through randomization software, and since we want the percentage of alcoholism to be the same in both groups, at the time of randomization, alcoholism is considered as a category. And we will use stratified randomization and finally 60 patients will be evaluated in each group, Blinding description: In this study, blinding is done and it is a single-blinded (the person who fills in the questionnaire. 3 Chronic anal fissure. Intervention 1: Intervention group: treatment is in the form of pediatric glycerin suppository 1 g, 5 minutes after using lidocaine ointment and diltiazem every morning, and the use of lidocaine and diltiazem ointment is the same as the control group every 8 hours during the day; Some lubricant gel can be impregnated around the suppository to facilitate passage. Iran Najo Pharmaceutical Co. Tehran-Iran. Intervention 2: Control group: Treatment of fissure in this group is using a topical combination of lidocaine ointment and diltiazem 2% every 8 hours. Yes - There is a plan to make this available What will be shared: Information on the complications of the disease before treatment and changes after treatment can be shared. When: four months after the end of the clinical trial (February 2021) To whom: Researchers working in academic and scientific institutions Conditions: According to the statistical analyzes, the data are evaluated and in case of positive results, this new treatment and intervention can be used as a new treatment and reduction of complications from previous treatments such as surgery in patients with chronic anal fissure. Where to obtain: Dr. Mohammad Islamian - General Surgeon - Isfahan University of Medical Sciences- mr.esl67@gmail.com How to obtain: After the trial, the data are processed and reported within one to two months, depending on the type of variables and the type of statistical analysis, with the cooperation of a statistical consultant Comments: The course of future releases will be announced in more detail
public Mohammad Eslamin
Al-Zahra University Hospital, Soffe Blvd
Isfahan Iran (Islamic Republic of) 81746 75731 +98 31 3620 2020 mr.esl67@gmail.com Esfahan University of Medical Sciences scientific Mohammad Eslamian
Al-Zahra University Hospita, Soffe Blvd
Isfahan Iran (Islamic Republic of) 81746 75731 +98 31 3620 2020 mr.esl67@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Posterior or anterior fissure No previous history of autoimmune disease No history of immunodeficiency disease No history of previous gastrointestinal cancer People over 40 years of age with normal colonoscopy No risk factor including weight loss during 6 Last month No anorexia No history of gastrointestinal genetic cancers (such as FAP, HNPCC) If a person is positive with FIT or a person with iron deficiency anemia, if he has a normal colonoscopy and endoscopy can be included in the study no limit no limit Both Reluctance to continue treatment smoking and spicy spices K60.1 Chronic anal fissure Treatment - Drugs Treatment - Drugs Intervention group: treatment is in the form of pediatric glycerin suppository 1 g, 5 minutes after using lidocaine ointment and diltiazem every morning, and the use of lidocaine and diltiazem ointment is the same as the control group every 8 hours during the day; Some lubricant gel can be impregnated around the suppository to facilitate passage. Iran Najo Pharmaceutical Co. Tehran-Iran Control group: Treatment of fissure in this group is using a topical combination of lidocaine ointment and diltiazem 2% every 8 hours. 1) Patients' pain score 2) Percentage of constipation improvement in the intervention group 3) Percentage of bleeding improvement in the intervention group 4) Percentage of improvement of incomplete stool discharge in the intervention group 5) Percentage of burning sensation in the intervention group 6) Percentage of itching improvement in the intervention group. Timepoint: 1) Pain score of the intervention group with the control group before and after treatment (first day, second weekend, fourth weekend) 2) constipation of the intervention group and control group (first day, second weekend, fourth weekend) 3) bleeding Intervention group and control group (first day, second weekend, fourth weekend) 4) incomplete defecation of the intervention group and control group (first day, second weekend, fourth weekend) 5) burning of the intervention group and control group (first day , Second weekend, fourth weekend) 6) itching Intervention and control group (first day, second weekend, fourth weekend). Method of measurement: 1) Measuring pain through Visual Analogue Scale 2) Percentage of improvement of constipation through checklist 3) Percentage of improvement of bleeding through checklist 4) Percentage of improvement of incomplete stool discharge through checklist 5) Percentage of improvement of burning through checklist 6) Percentage of itching recovery through checklist. 1) Headache improvement 2) Quality of life indicators score. Timepoint: 1) Improvement of headache after treatment (second weekend, fourth weekend) 2) score of quality of life indicators before and after treatment (first day, second weekend, fourth weekend). Method of measurement: 1) Improvement of headache through a checklist 2) Score of quality of life indicators based on WHO-QOL 100 questionnaire. Esfahan University of Medical Sciences Approved 2021-07-16 Research Ethics Committees of Isfahan University of Medical Sciences Deputy of Research and Technology- Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)