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IRCT20160808029264N10 IRCT 2021-04-13 Semnan University of Medical Sciences The effects of laser therapy in patients with COVID-19 The short-term and long-term effects of laser therapy on pulmonary function and inflammatory factors in patients with COVID-19 during acute stage 2021-04-03 anticipated 30 Complete https://irct.ir/trial/54655 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method using a random number table, individuals will be randomly divided into two groups including intervention and control. Random units are each of patients infected with covid-19 that admitted to the emergency department. Also, The randomization tool is a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified, Blinding description: Patients will be blinded whether they are in the active or sham LASER group (the laser device will be used at the same points and for the same duration, which will be set on in the intervention group and off in the control group). In addition, the evaluator will not aware which patient assigned in two groups. N/A Respiratory infection due to COVID-19. Intervention 1: Intervention group: standard treatment associated with High-power laser (lumix® 3 model manufactured by Italian physioline company) for 5 sessions every other day with C.P.S anti-inflammatory protocol and 3600 per session for 30 minutes, which is applied for 15 minutes per lung. Standard treatment Includes supplemental oxygen (if needed), non-invasive ventilation, antibiotics (oral and injectable if needed), supportive vasopressor, artificial kidney (renal-replacement therapy), and extracellular membrane oxygenation. Intervention 2: Control group: Standard treatment associated with the sham-laser are applied to similar points on the lungs for 30 minutes. 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 Dr Rasool Bagheri
Ghods Ave., Neuromuscular Rehabilitation Research Center
Semnan Iran (Islamic Republic of) 35147-99442 +98 23 3365 4180 rasool.bagheri@ymail.com Semnan University of Medical Sciences scientific Dr Rasool Bagheri
Ghods Ave., Neuromuscular Rehabilitation Research Center
Semnan Iran (Islamic Republic of) 35147-99442 +98 23 3365 4180 Rasool.bagheri@ymail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Positive PCR test The ratio below 300 mm Hg for the pressure of oxygen (Pao2) to the inspired oxygen (Fio2) Hospitalized in the internal or special ward of the hospital Severe pulmonary involvement based on CT scan Severe stage of the disease 18 years 65 years Both Intubation of the patient Ratio more than 300 mm Hg Mild to moderate severity of the disease Diseases such as lung and spinal cancer, heart disease, high high blood pressure and any conditions that are contraindicated for laser therapy. B34.2 Coronavirus infection, unspecified Rehabilitation Rehabilitation Intervention group: standard treatment associated with High-power laser (lumix® 3 model manufactured by Italian physioline company) for 5 sessions every other day with C.P.S anti-inflammatory protocol and 3600 per session for 30 minutes, which is applied for 15 minutes per lung. Standard treatment Includes supplemental oxygen (if needed), non-invasive ventilation, antibiotics (oral and injectable if needed), supportive vasopressor, artificial kidney (renal-replacement therapy), and extracellular membrane oxygenation. Control group: Standard treatment associated with the sham-laser are applied to similar points on the lungs for 30 minutes. Pneumonia severity indices. Timepoint: Before and after the study. Method of measurement: Pulmonary CT-scan. Laboratory tests. Timepoint: Before and after the study. Method of measurement: Inflammatory factors such as Interleukin-6, ferritin, C-reactive protein, Erythrocyte sedimentation rate and blood factors. Semnan University of Medical Sciences Approved 2021-02-26 Ethics committee of Semnan University of Medical Sciences Basij Blvd., Semnan University of Medical Sciences. Semnan Semnan Iran (Islamic Republic of)