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IRCT20191223045868N1 IRCT 2020-03-28 Gonabad University of Medical Sciences Effect of Oral Drop Mentha spicata (Supermint) on Gastric Residual Volume in Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit Effect of Oral Drop Mentha spicata (Supermint) on Gastric Residual Volume in Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit 2020-06-21 anticipated 60 Complete https://irct.ir/trial/46580 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization: Permuted block randomization with a fixed block size of 4 Unit of randomization: Individual Tools used in randomization: sealed envelops, computer software How the random sequence is built: Random allocation software How allocation concealment is carried out: Sequentially numbered, sealed, opaque envelopes, Blinding description: Patients in both groups are unaware of the treatment being used. The intervention and the assessment of the result are performed by two different individuals, and so the result assessor will not be informed of the form of treatment being allocated. For the gavage material, A and B codes are considered, and the data analyzer is not told the type of gavage material. N/A Gastric Residual Volume. Intervention 1: Intervention group: Patients in the intervention group receive 20 drops of the Supermint solution along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding. Intervention 2: Control group: Patients in the control group receive 20 drops of the plasebo along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding. 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 Its release schedule is still unclear.
public Ali Delshad Noghabi
Gonabad University of Medical Sciences, Asian Road Border
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 ali_delshad2000@yahoo.com Gonabad University of Medical Sciences scientific Ali Delshad Noghabi
Gonabad University of Medical Sciences, Asian Road Border
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 ali_delshad2000@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) All patients under mechanical ventilation with >24 hours stay in the intensive care unit (ICU) Ages between 18 to 65 years old Informed consent of parents or legal guardian 18 years 65 years Both Having gallstones History of active gastrointestinal bleeding, malignancies, gastrointestinal ulcer, diabetes and pancreatitis Pregnancy and breastfeeding History of Hypothyroidism according to the statement of people accompanying the patient Oral nutrition or use of a duodenal catheter K31.9 Disease of stomach and duodenum, unspecified Prevention Placebo Intervention group: Patients in the intervention group receive 20 drops of the Supermint solution along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding. Control group: Patients in the control group receive 20 drops of the plasebo along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding. Gastric Residual Volume. Timepoint: Before each gavage during the study. Method of measurement: By aspirating the stomach contents with a 60 ml syringe. Gonabad University of Medical Sciences Approved 2020-02-25 Research Ethics Committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Asian Road Border Gonabad Razavi Khorasan Iran (Islamic Republic of)