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IRCT20150830023823N3 IRCT 2020-12-06 Shiraz University of Medical Sciences Efficacy of Barley water (Hordeum vulgare) in clinical outcome of COVID-19 patients Efficacy of Barley water (Hordeum vulgare) in clinical outcome of COVID-19 patients hospitalized in Shiraz: a single blind, randomized controlled clinical study 2020-11-15 anticipated 50 Complete https://irct.ir/trial/50854 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: we use permutation block randomization method with block size of 4.Selected samples based on these blocks are placed in intervention (A) and control (B) groups. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB, Blinding description: The product is given by the nurse and the Investigator is blinded. 3 COVID-19. Intervention 1: Intervention group: current medications for this disease according to the approved protocol, in addition to 250 cc of barley water daily (around 11 am). Intervention 2: Control group: current medications for this disease according to the approved protocol. 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 Confidential of data
public Ali Tavakoli
Zand street
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences scientific Ali Tavakoli
Zand street
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with a definitive diagnosis of pneumonia (pneumonitis) caused by COVID 19 according to the national guidelines for the new corona virus that hospitalized in selected hospitals for corona virus in Shiraz. Patients are not in the severe group and do not need care in the intensive care unit (ICU care) age>18 Patients don't receive antiviral medication prior to enrollment. The disease is confirmed by PCR or CT scan. 18 years no limit Both Pregnancy Chronic kidney disease History of allergy to barley U07.1 COVID-19, virus identified Treatment - Other Treatment - Drugs Intervention group: current medications for this disease according to the approved protocol, in addition to 250 cc of barley water daily (around 11 am). Control group: current medications for this disease according to the approved protocol Fever. Timepoint: Before and after the intervention In the form of daily. Method of measurement: Thermometer. Cough. Timepoint: daily. Method of measurement: Patient history. Respiratory rate. Timepoint: daily. Method of measurement: visual by nurse. Chills. Timepoint: daily. Method of measurement: Patient history. Body pain. Timepoint: daily. Method of measurement: Patient history with Visual Analog Scale. Duration of hospitalization. Timepoint: daily. Method of measurement: patient chart. Duration of recovery of each of the clinical symptoms(fever, dry cough, respiratory rate). Timepoint: daily. Method of measurement: clinical symptoms registration form according to the national guidelines of the new corona virus. Side effect such as nausea, bloating and constipation. Timepoint: daily. Method of measurement: drug side effect registration form. CRP. Timepoint: Start and end of the intervention. Method of measurement: Biochemical Auto analyzer Instrument. Shiraz University of Medical Sciences Approved 2020-05-05 Ethics committee of Shiraz University of Medical Sciences Zand street Shiraz Fars Iran (Islamic Republic of)