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IRCT20220124053820N1 IRCT 2022-09-19 Research deputy of Rasht Islamic Azad University and Zist Takhmir company Investigation the effect of probiotics in patients with COVID-19 The effect of probiotics as an adjunctive therapy with mortality outcome, length and rate of hospitalization in Intensive Care Unit in patients with COVID-19 2022-09-06 anticipated 60 Complete https://irct.ir/trial/65293 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To equalize the number of patients in two groups, block randomization method is used. For randomization, random fixed block method is used in blocks of 4. In such a way that two samples from the experimental group and two samples from the control group are allocated in each block, Blinding description: Patients in two groups do not know which group they are in. For this reason, placebo is used to pay attention to the psychological aspect and acceptance of the patient. The infectious disease specialist who is in charge of treating the patients also does not know which group the patient belongs to. The patient assessor, who collects data related to the disease and outcomes, does not know which group the patient belongs to. Patients (experimental group or control group) receive the medicine in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the patient, doctor and evaluator are blinded. 0 (exploratory trials) COVID-19. Intervention 1: The intervention group receives probiotic Lactocare 500 mg capsules produce by Zist Takhmir company twice a day in addition to the treatment prescribed by the infectious disease specialist. Intervention 2: The control group receives the treatment prescribed by the infectious disease specialist along with the placebo capsules produced by Zist Takhmir company twice a day. 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 The decision to publish the study will be made after the study is completed.
public Dr Shadi dehghanzadeh
Rasht Islamic Azad University,Pole taleshan, rasht
Rasht Iran (Islamic Republic of) ۵۴۹۱۹-۴۱۴۷۶ +98 54 9194 1476 shadidehghan90@gmail.com Rasht Islamic Azad University scientific Dr Aydin Pourkazemi
Guilan University of Medical Sciences, Parastar Ave, Rasht
Rasht Iran (Islamic Republic of) 4193713111 +98 13 3332 6061 Aydinpourkazemi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients who are hospitalization due to COVID-19. Patients should be 18 years old and older. Patients should have clinical symptoms and pneumonia of covid in chest radiography or CT scan. Patients should not particitaion in other clinical trials at the same time. 18 years no limit Both COVID-19 COVID-19 Treatment - Drugs Treatment - Drugs The intervention group receives probiotic Lactocare 500 mg capsules produce by Zist Takhmir company twice a day in addition to the treatment prescribed by the infectious disease specialist. The control group receives the treatment prescribed by the infectious disease specialist along with the placebo capsules produced by Zist Takhmir company twice a day. Need to admission to ICU. Timepoint: Daily. Method of measurement: By evaluator using patient's file and ward's information. Need to intubation. Timepoint: Daily. Method of measurement: By evaluator using patient's file and ward's information. Mortality. Timepoint: Daily. Method of measurement: By evaluator using patient's file and ward's information. Vital signs. Timepoint: Three times a day. Method of measurement: By evaluator using mercury sphygmomanometer and tاermometer. Symptoms consisting cough, dyspnea, diarrhea, abdominal pain. Timepoint: Daily. Method of measurement: By evaluator asking patient and patient's file. O2 saturation. Timepoint: Three times a day. Method of measurement: By evaluator using pulse oxymeter. Laboratories tests: Hb, Platelet, ESR, CRP, WBC, lymphocyce, NLR, CPK, ALT, AST, fibrinogen, D-dimer. Timepoint: Daily. Method of measurement: By Razi Hospital Laboratory. Length of hospitalization. Timepoint: Daily. Method of measurement: By evaluator by pstient's file. Research deputy of Rasht Islamic Azad University and Zist Takhmir company Approved 2022-06-12 Thics committee of Lahijan Islamic azad University Islamic azad University Lahijan branch, 45 meter university Blvd, lahijan lahijan Guilan Iran (Islamic Republic of)