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IRCT20190701044062N7 IRCT 2021-07-14 Tabriz University of Medical Sciences The effect of Sodium Pentaborate In Anal fissure Evaluation of the effect of Sodium Pentaborate Topical Ointment on Anal fissure symptoms and treatment 2020-09-05 anticipated 140 Complete https://irct.ir/trial/52206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: ratio of 2 for sample size in intervention group to placebo group was considered and 129 patients (intervention group 86 cases, placebo group 43 cases) were needed to give a 80% chance of finding a 25% difference in healing between placebo and GTN at the 5% level. This number was increased by 10% to consider attrition or incomplete data. Finally, 140 cases (90 in intervention and 50 in placebo group) were recruited, Randomization description: The block randomization method will be used to assign patients to the intervention and control groups with the ratio of 2 for sample size in intervention group to placebo group. The size of the blocks is 6. ( Due to the difficulty in patient recruitment, we considered ratio of 2:1 for sample size in intervention group to placebo group to have more patients in intervention group). Randomization was performed using https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 11 Jul 2021]. Allocation concealment will be done using matte sealed envelopes, Blinding description: A gel that has an active ingredient in boron with a gel of placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). All ointments were either transparent and gelatinous and put in identical tubes by staff not involved further in the trial. Identical tubes were labeled as A and B. When the physician saw chronic anal fissure on anal examination and the patient has inclusion criteria of the study gave patients A code and B code tubes, respectively. In some hospitals, active molecules were put in A coded tube, and some hospitals in B coded tubes. The randomization codes remained in the pharmaceutical company staff who prepared the drug during the trial and was not available to the investigators. After collecting the data and completing the data analysis stage, the nature of the codes related to the groups will be revealed by the liaison person in the pharmaceutical company. The important point is that the patient is told that the gel used for the patient may be medication or medication. In blinding, the physician, patient, data analyzer, and researcher will be blind. 2-3 Anal fissure. Intervention 1: Intervention group: Topical ointment of 3% sodium pentaborate, which is made under GLP and GMP conditions at Yeditpe University in Turkey and is applied to the wound for 14 days (2 weeks) twice a day in the size of a fingertip. The patient is taught for 15 to 30 minutes by an experienced and trained expert. Intervention 2: Control group: These are the group that take placebo ointment that has no therapeutic properties. It is worth mentioning that the participants in this project are patients with chronic anal fissure who have not previously responded to routine treatment (increased consumption of dietary fiber and nifedipine ointment) and for this reason, placebo was used for the control group. We remind you that according to the inclusion criteria, patients should not have used any topical anal drug for at least the last 7 days. Yes - There is a plan to make this available What will be shared: Part of the data, which includes information about the main outcome and results, will be shared. When: available from April 2021 To whom: University researchers and professors Conditions: The data will be available to researchers and university professors for the studies of the meta - analysis. Where to obtain: Email: niloofarafshin1375@gmail.com نیلوفر افشین How to obtain: Request via email: niloofarafshin1375@gmail.com As soon as possible Comments:
public Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3335 9680 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Chronic anal fissure that is detected in the perineal area by direct observation or rigid anoscopy or flexible colonoscopy. 18 years no limit Both Existence of any perineal complications including dermatitis, wart, condyloma, hemorrhoids, fistula, anal abscess 2. Proven Crohn's disease 3. Existence of lateral fissure 4. Patients with sodium pentaborate allergy 5. Pregnancy or breastfeeding 6. Patients with a history of serious cardiovascular, hepatic, renal and blood diseases 7. Taking any topical anal medication during the last 7 days 8. Prohibition of topical use of sodium pentaborate being under the age of 18 K60.2 Anal fissure, unspecified Treatment - Drugs Placebo Intervention group: Topical ointment of 3% sodium pentaborate, which is made under GLP and GMP conditions at Yeditpe University in Turkey and is applied to the wound for 14 days (2 weeks) twice a day in the size of a fingertip. The patient is taught for 15 to 30 minutes by an experienced and trained expert. Control group: These are the group that take placebo ointment that has no therapeutic properties. It is worth mentioning that the participants in this project are patients with chronic anal fissure who have not previously responded to routine treatment (increased consumption of dietary fiber and nifedipine ointment) and for this reason, placebo was used for the control group. We remind you that according to the inclusion criteria, patients should not have used any topical anal drug for at least the last 7 days. Anal itching. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. Anal bleeding. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient, inspection of anus and digital rectal examination. Anal pain at rest. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. Anal pain during defecation. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. Bleeding from the fissure during the examination. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Inspection of anus and digital rectal examination. Pain at the Fissure site during the examination. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient, inspection of anus and digital rectal examination. Anal pain during defecation. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. Feeling of a mass around the anus. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. Tabriz University of Medical Sciences Approved 2020-08-10 Ethics committee of Tabriz University of Medical Sciences Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)