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IRCT20190712044182N1 IRCT 2019-08-27 Iran University of Medical Sciences Effect of arginine on chronic anal fissure The effects of arginine supplementation on clinical symptoms, quality of life and anal internal sphincter pressure in patients with chronic anal fissure 2019-07-28 anticipated 76 Complete https://irct.ir/trial/41078 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadrilateral blocks. According to the sample size of 76 that has been set, 19 blocks will be produced by using the online site "www.sealedenvelope.com". In order to apply the concealment in the randomization process, unique codes will be used on supplement boxes, the code being generated by the software. By entering each individual into a study based on the generated sequence, the supplement package with the specific code will be allocated to the individual, and therefore, before the person is selected, nobody aware of the type of treatment he will receive, Blinding description: In this study, participants, researchers, evaluators of the outcomes, and data analyzers will be blinde to the type of intervention. 3 chronic anal fissure. Intervention 1: Intervention group: L-arginine supplement, manufactured by Karen Company, 90 capsules consumed 3 times daily (3 grams of arginine per day) with their meals for one month. Intervention 2: Control group: placebo manufactured by Karen Company, 90 capsules consumed 3 times daily with their meals for one month. Yes - There is a plan to make this available What will be shared: Information about the main consequences will be shared. When: Start the access period, 6 months after publication of results To whom: Physicians, nutritionist, patients with anal fissure and constipation Conditions: Published as an article Where to obtain: Masoumeh Khalighi Sikaroudi gmail adress: masoomehkhalighi@gmail.com How to obtain: mail will be sent to the main author or co-response, and in less than 1 week, the available data will send to the individual. Comments:
public Masoumeh Khalighi Sikaroudi
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan St.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6655 4790 masoomehkhalighi@gmail.com Iran University of Medical Sciences scientific Masoumeh Khalighi Sikaroudi
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan St.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6655 4790 masoomehkhalighi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Chronic Anal Fischer Fisher in the posterior and anterior areas of the anus Non-pregnant and lactating women Age: 18 - 65 years BMI: 18.5 - 35 kg/m2 Non-specific digestive diseases such as Crohn's disease, Ulcerative colitis, gastrointestinal cancers and etc. The absence of diseases that fissure can be their complications: tuberculosis, AIDS, syphilis, herpes, leukemia and etc. No history of malignancy or malignancy in present No history of heart disease No history of fissure and hemorrhoid surgery 18 years 65 years Both K60.1 Chronic anal fissure Treatment - Other Placebo Intervention group: L-arginine supplement, manufactured by Karen Company, 90 capsules consumed 3 times daily (3 grams of arginine per day) with their meals for one month. Control group: placebo manufactured by Karen Company, 90 capsules consumed 3 times daily with their meals for one month. Clinical symptoms (bleeding). Timepoint: at the beginning and the end of the study. Method of measurement: Visual Analogue Scale. Clinical symptoms (pain). Timepoint: at the beginning and the end of the study. Method of measurement: Visual Analogue Scale. Clinical symptoms (improve ulcer ). Timepoint: at the beginning and the end of the study. Method of measurement: Visual Analogue Scale. Quality of life. Timepoint: at the beginning and end of the study. Method of measurement: General Health Survey Short Form-36. Internal anal sphincter pressure. Timepoint: at the beginning and end of the study. Method of measurement: manometry. Iran University of Medical Sciences Approved 2019-06-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemat highway Tehran Tehran Iran (Islamic Republic of)