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IRCT20210222050457N1 IRCT 2021-04-20 Kashan University of Medical Sciences Determining the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in reducing the length of hospital stay of patients with Covid-19 Determining the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray on reducing the length of hospital stay of patients with Covid-19 2021-03-04 anticipated 188 Complete https://irct.ir/trial/54525 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the intervention and control groups were coded with the letter A and Bm respectively, and then randomization list will be prepared using the website www. sealedenvelope.com/simple-randomiser/v1/lists via selecting a sample size of 188 (two groups of 94) and permuted block randomization method (block size=4), (47 blocks of 4). Then, the subjects included in the study will be assigned to one of the two groups A or B through the obtained randomization list. For example, suppose that the permutation method is ABBA in the first four blocks, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will be continued until the last sample (188th person). 1-2 Covid-19. Intervention 1: Intervention group: In addition to the routine treatment regimen, patients will receive a puff of PHR spray 160 (6 micrograms per puff) using a spacer,10 times a day during10 days. PHR160 spray made by Jabr Ibn Hayan Pharmaceutical Company was used in this trial. Intervention 2: Control group: They will receive control of the usual treatment for the disease according to the normal treatment regimen of the hospital including one 250 mg naproxen tablet every 12 hours (for 5 days), 500 mg azithromycin on the first day, and 250 mg on the second to fifth days, 40 mg famotidine every 12 hours for 5 days, and 25 mg prednisolone daily for 5 days. 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 more information
public Reza Razzaqi
Kashan University of Medical Sciences, Qotb –e Ravandi Blvd., Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5472 5800 rrazzaghi33@gmail.com Kashan University of Medical Sciences scientific Fatemeh Shirvani Arani
Health Center, Imam Khomeini Boulevard, Aran O Bidgol
Aran O Bidgol Iran (Islamic Republic of) 8741646949 +98 31 5472 5800 Dr.shirvanizade@gmail.com Aran O Bidgol Health Center Iran (Islamic Republic of) Male or female patients aged 18 to 75 years with COVID-19 who have been diagnosed with a lung scan, PCR, or clinical examination. Obtaining informed consent from the patient or patient caregiver to participate in the study 18 years 75 years Both Cancer patients undergoing chemotherapy Patients with immunodeficiency diseases receiving immunomodulators Patients with uncontrolled heart, kidney or liver failure Women who are pregnant or breastfeeding Patients with low level of consciousness who are not able to inhale the spray U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: In addition to the routine treatment regimen, patients will receive a puff of PHR spray 160 (6 micrograms per puff) using a spacer,10 times a day during10 days. PHR160 spray made by Jabr Ibn Hayan Pharmaceutical Company was used in this trial. Control group: They will receive control of the usual treatment for the disease according to the normal treatment regimen of the hospital including one 250 mg naproxen tablet every 12 hours (for 5 days), 500 mg azithromycin on the first day, and 250 mg on the second to fifth days, 40 mg famotidine every 12 hours for 5 days, and 25 mg prednisolone daily for 5 days. Percentage of arterial oxygen saturation. Timepoint: Before and after intervention on a daily basis. Method of measurement: Pulse oximeter. Severity of cough. Timepoint: Before and after intervention on a daily basis. Method of measurement: Based on the degree of severity. Shortness of breath. Timepoint: Before and after intervention on a daily basis. Method of measurement: Based on the degree of severity. Length of stay in hospital. Timepoint: By day. Method of measurement: Number of days. ICU admision time. Timepoint: By day. Method of measurement: Number of days. Kashan University of Medical Sciences Approved 2021-02-19 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Qutb Ravandi Blvd., Kashan Kashan Isfehan Iran (Islamic Republic of)