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IRCT20190414043275N1 IRCT 2021-07-05 Tehran University of Medical Sciences Diltiazem in fissure comparison of the effectiveness topical diltiazem and nefidipin in improving symptom and healing in patient with acute fissure 2021-07-22 anticipated 140 Complete https://irct.ir/trial/51006 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization approach will be implemented in this study. Randomization will be performed using a computer-generated list. For this purpose, 140 sealed ‎envelopes will be numbered 1-140 according to the randomization list. Group allocation ‎will be kept separate until the study is completed. The randomization ratio would be 1: 1, with 70 ‎envelopes allocated to each group, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants are aware of the type of treatment. 4 Acute anal fissure. Intervention 1: Group-A will received 0.3% nifedipine ointment, Synthesized in the pharmacy of Razi Hospital affiliated to Tehran University of Medical Sciences, Peri-anally , three times a day, quantity of a knuckle for 2 months. Intervention 2: Group-B will treated by 2% diltiazem ointment (Sobhan Company) , Peri-anally , three times a day, amount of a knuckle for 2 months. 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 no any more information
public zahra momayez sanat
jalale ale ahmad shariati hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 84901 msanat67@gmail.com Tehran University of Medical Sciences scientific zahra momayez sanat
jalale ale ahmad shariati hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8863 3039 msanat67@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Acute fissure 18 years no limit Both Pregnancy history of anal surgery Anorectal malformation K60.0 Acute anal fissure Treatment - Drugs Treatment - Drugs Group-A will received 0.3% nifedipine ointment, Synthesized in the pharmacy of Razi Hospital affiliated to Tehran University of Medical Sciences, Peri-anally , three times a day, quantity of a knuckle for 2 months Group-B will treated by 2% diltiazem ointment (Sobhan Company) , Peri-anally , three times a day, amount of a knuckle for 2 months Duration of pain. Timepoint: Before the intervention, every week for up to 8 weeks after the intervention. Method of measurement: Question from the patient. Healing of anal fissure. Timepoint: After two months of intervention. Method of measurement: Physical examination. Relapse. Timepoint: 6 months after intervention. Method of measurement: Question from the patient. private Approved 2020-09-07 Ethics committee of tehran university of medical science jalal al ahmad shariati hospital Tehran Tehran Iran (Islamic Republic of)