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IRCT20221203056698N1 IRCT 2023-10-11 Tabriz University of Medical Sciences Effect of new combination gel in the treatment of acute anal fissures Comparison of the effectiveness of combination gel (diltigel2%-ureacolchicine) with diltigel 2% in the treatment of acute anal fissures 2023-12-10 anticipated 80 Complete https://irct.ir/trial/67183 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients after entering the study in blocks of four in two groups will be divided. Since the primary investigator of this study is the prescribing physician, he is able to be blinded will not be in the course of study; But the person analyzing the data will be unaware of the type of patient grouping The study flow will be blind; Therefore, the present study will be a single-blind study, Blinding description: After entering the study, patients will be divided into two groups in blocks of four. Since the first conductor of this study is the prescribing physician, he will not be able to be blind during the study; However, the person analyzing the data as well as evaluating the results, who will be unaware of the type of patient grouping, will be blind during the study; Therefore, the present study will be a double-blind study. 2-3 Condition 1: Acute anal fissures. Condition 2: Acute anal fissures. Intervention 1: Intervention group: For the patients of this group, 2% Diltigel gel will be administered externally once every twelve hours. Intervention 2: Intervention group: For the patients of the other group, a gel prepared by a pharmacist in the form of a combination of 30 grams of Diltigel 2%, 67 grams of urea, and 3 grams of colchicine will be prescribed twice a day and externally. 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 In case of contradiction with the previous data and inconsistency of the results obtained with the previous methods, the final decision will be taken
public Ramin Azhugh
Golgasht
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 6047 danesh@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ramin Azhugh
Golgasht
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3333 5698 danesh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Consent to participate in the study Suffering from acute anal fissure as diagnosed by a specialist doctor 18 years 75 years Both Having IBD Receiving chemotherapy drugs Being under radiotherapy History of Fisher and hemorrhoid surgery Receiving medicine and herbal gel for the treatment of fissure Receiving Diltigel before entering the study Receiving lidocaine and tetracycline before entering the study Having gout History of uncontrolled blood pressure Allergy to the drugs used in this study K60.2 K60.2 Anal fissure, unspecified Anal fissure, unspecified Treatment - Drugs Treatment - Drugs Intervention group: For the patients of this group, 2% Diltigel gel will be administered externally once every twelve hours. Intervention group: For the patients of the other group, a gel prepared by a pharmacist in the form of a combination of 30 grams of Diltigel 2%, 67 grams of urea, and 3 grams of colchicine will be prescribed twice a day and externally. The amount of pain in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of pain will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin. The intensity of pain will be checked with the help of visual pain scale (VAS). The amount of itching in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of itching will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person. The amount of bleeding in the follow-up periodPatients will be asked. Timepoint: Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit). Method of measurement: The intensity of bleeding will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of tabriz University of Medical Sciences golgasht,Tabriz University of Medical Sciences tabriz East Azarbaijan Iran (Islamic Republic of)