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IRCT20150221021159N6 IRCT 2021-04-04 Esfahan University of Medical Sciences The effect of HemoHIM supplement for the prevention of ventilator associated pneumonia Evaluation of the effect of HemoHIM supplement for the prevention of ventilator associated pneumonia in critically ill patients 2021-05-22 anticipated 30 Complete https://irct.ir/trial/54788 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Restricted randomization with the permuted block method was used to create the random sequence and balance the number of allocated samples in each group (control and HemoHIM). The computer program was used for a random sequence in blocks of 2, 4, and 6. Each block has an equal number of control and HemoHIM groups. It is written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group. 3 Ventilator associated pneumonia. Intervention 1: Intervention group: In addition to the standard care conducted in ICU for preventing ventilator-associated pneumonia, a packet of HemoHIM supplement containing 20 cc of herbal extract manufactured by KolmarBNH Sun Biotech Business (SBT) company of Korea is used daily and orally for 7 days. Intervention 2: Control group: Receive standard care of the intensive care unit to prevent ventilator-associated pneumonia, such as head elevation. 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 There is no further information.
public Shadi Farsaei
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7071 Farsaei@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Shadi Farsaei
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7071 Farsaei@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Gaining informed consent Adult patients undergoing mechanical ventilation for more than 48 hours 18 years no limit Both Diagnosis of acute respiratory distress syndrome or pneumonia at intensive care unit (ICU) admission Existence of immunodeficiency and leukopenia J95.851 Ventilator associated pneumonia Prevention N/A Intervention group: In addition to the standard care conducted in ICU for preventing ventilator-associated pneumonia, a packet of HemoHIM supplement containing 20 cc of herbal extract manufactured by KolmarBNH Sun Biotech Business (SBT) company of Korea is used daily and orally for 7 days. Control group: Receive standard care of the intensive care unit to prevent ventilator-associated pneumonia, such as head elevation Incidence of ventilator associated pneumonia. Timepoint: Evaluation of the occurrence of ventilator associated pneumonia daily, during 14 days after study recruitment. Method of measurement: Calculate the clinical pulmonary infection score (CPIS) table. Isfahan University of Medical Sciences Approved 2021-03-03 Ethics committee of Isfahan University of Medical sciences Bldg No. 4, Isfahan University of Medical Sciences and Health Services, Hizar jarib street Isfahan Isfehan Iran (Islamic Republic of)