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IRCT20200411047029N1 IRCT 2021-04-24 The Research Institute of Food and Secrets TAAMASRAR Effectiveness of PHR-160 spray in recovery of hospitalized patients with Covid-19 in Isfahan province in 1399 ISF PHR-160 Study Evaluation of the effectiveness of PHR-160 spray in recovery of hospitalized patients with Covid-19 in Isfahan province in 1399 2021-04-21 anticipated 198 Complete https://irct.ir/trial/55615 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: If patients agree to participate, they will be placed in one of two intervention or control groups in the random allocation project using SPSS software. For this purpose, they are numbered from 1 to 198 in SPSS software. Then, using RANDOM SAMPLING, we select 50% of the samples and place the selected samples in the CASE group and the deleted samples in the control group. Intervention and control group: 1. Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment 2. Control group: placebo spray containing proplant (HFA gas which is a carrier and inert) in double puff every 2 hours (except sleeping hours), along with the national standard treatment, Blinding description: Blinding: Three-way blind Blind groups in the study: participant research fellow Analyzer The study will be blinded in three ways. Patients will be blinded to the type of intervention, as well as the researcher who must enter the data into the relevant checklist, and the data analyzer will be blinded to the type of intervention. 3 COVID-19. Intervention 1: Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment. Intervention 2: Control group: Placebo spray containing proplant (HFA gas that is carrier and inert) in two puffs every 2 hours (except sleeping hours), along with the national standard treatment. Yes - There is a plan to make this available What will be shared: After de-identifying the outcome data When: Six months after the article is published To whom: The data will only be available to researchers working at academic institutions. Conditions: In order to spread the knowledge and with the permission of the research team Where to obtain: The person responsible for updating the data How to obtain: Via email after evaluation Comments:
public Ramin Sami
Hezar Jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3222 2892 r.sami@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ramin Sami
Hezaer Jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3222 2892 r.sami@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age more than 18 years Definite diagnosis of SARS-CoV-2 virus based on PCR Diagnosis of pneumonia consistent with lung involvement with COVID-19 on CT scan Need to be admitted to the ICU at the beginning of hospitalization 18 years no limit Both Having comorbidities (chronic kidney failure, cirrhosis, severe heart failure (less than 25% EF), active or untreated cancer) Pregnancy and breastfeeding Patients with hepatic enzymes including aspartate transaminase (AST) and alanine transaminase (ALT) at 5 times more than normal amount U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment Control group: Placebo spray containing proplant (HFA gas that is carrier and inert) in two puffs every 2 hours (except sleeping hours), along with the national standard treatment Duration and severity of symptoms (cough and shortness of breath). Timepoint: Daily. Method of measurement: Case file-Query from patients. Duration of hospitalization. Timepoint: Daily. Method of measurement: Case file. Blood oxygen levels. Timepoint: Daily. Method of measurement: Pulse Oximeters. Requirement for ICU admission. Timepoint: Daily. Method of measurement: Doctor diagnosis. Duration of hospitalization in the ICU. Timepoint: Daily. Method of measurement: Case file. Death rate. Timepoint: Daily. Method of measurement: Case file. The Research Institute of Food and Secrets TAAMASRAR Approved 2021-04-11 School of Medicine, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)