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IRCT20180412039283N2 IRCT 2021-03-10 Shahid Beheshti University of Medical Sciences Investigation of the Effect of Senagraph on colon preparation Comparison of low dose PEG (polyethylene glycol) and low dose PEG with Sena grafin regarding bowel preparation quality in patients with chronic kidney disease 2021-03-05 anticipated 122 Complete https://irct.ir/trial/54317 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used block randomization method. Each block size was 2 by 2, and in total 16 blocks were considered. The sequence for packages within each block were:ABBA_BABA_BBAA_ABAB_AABB_BAAB. Then each were marked from 1 to 6 as above.After that the packages within blocks were sequentially numbered from 1 to 64.The random numbergenerator program was used, Blinding description: Patients and the ward staff who delivered the medicine to the patients and the doctor who performed the colonoscopy were unaware of the type of medicine. The analyst was also unaware of the type of preparation given during the analysis.one group received fluid containing Senozoid (90 mg) and 1000 ml of PEG (totally 1100 ml) while the other group received 100 ml of water and 1000 ml of PEG (totally 1100 ml). The containing boxes were the same and without label. 3 Chronic Kidney Disease. Intervention 1: "Intervention group": Patients in this group received a solution containing one and a half glasses of Senagraf syrup every 12 hours, each glass of which contained 60 cc and 90 mg of SENOZOID, and with 1000 cc of polyethylene glycol solution. In total it was about 1100 cc of oral solution, received 24 hours ago of colonoscopy. Intervention 2: "Control group": Patients in this group received a solution containing 1000 cc of polyethylene glycol solution and 100 cc of water (1100 cc in total) every 12 hours, 24 hours before colonoscopy. Yes - There is a plan to make this available What will be shared: All data is shared after unidendentifiable people When: 6 months after printing the results To whom: Researchers working in academic institutions Conditions: Use data to compare with other similar interventions Where to obtain: Farzaneh tolouei farzanehtolouei@yahoo.com How to obtain: Email request Comments:
public Meghdad Sedaghat
Nezamabad,Madani street,Emam Hossein hospital
Tehran Iran (Islamic Republic of) 1234569871 +98 21 7343 0000 sedaghat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Meghdad Sedaghat
Nezamabad,Madani street,Emam Hossein hospital
Tehran Iran (Islamic Republic of) 1234569871 +98 21 7343 0000 sedaghat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with Chronic Kidney Disease (GFR<60) who are candidates for colonoscopy 18 years no limit Both Patients needing dialysis or Patients with a GFR of less than 15 (Base on MDRD) N18 Chronic kidney disease (CKD) Treatment - Drugs Treatment - Drugs "Intervention group": Patients in this group received a solution containing one and a half glasses of Senagraf syrup every 12 hours, each glass of which contained 60 cc and 90 mg of SENOZOID, and with 1000 cc of polyethylene glycol solution. In total it was about 1100 cc of oral solution, received 24 hours ago of colonoscopy "Control group": Patients in this group received a solution containing 1000 cc of polyethylene glycol solution and 100 cc of water (1100 cc in total) every 12 hours, 24 hours before colonoscopy. Bowel preparation quality base on Ottawa score. Timepoint: 24 hours after receiving the solution. Method of measurement: perform colonoscopy and determine the Ottawa score. Blood Urea Nitrogen(BUN). Timepoint: Before the intervention, 24 hours and 48 hours after the intervention. Method of measurement: Blood biochemistry test. Ceratinin(Cr). Timepoint: Before the intervention, 24 hours and 48 hours after the intervention. Method of measurement: Blood biochemistry test. Sodium(Na). Timepoint: Before the intervention, 24 hours and 48 hours after the intervention. Method of measurement: Blood biochemistry test. Potasium(K). Timepoint: Before the intervention, 24 hours and 48 hours after the intervention. Method of measurement: Blood biochemistry test. Shahid Beheshti University of Medical Sciences Approved 2019-11-19 Ethics committee of Shahid Beheshti Univercity of Medical Sciences Koodakyari street.velenjak Tehran Tehran Iran (Islamic Republic of)