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IRCT20180209038673N6 IRCT 2022-04-26 Kashan University of Medical Sciences The effect of cinnora supplement therapy in patients with severe form of COVID-19 Evaluation of the effect of cinnora supplement therapy in patients with severe form of COVID-19 2022-01-10 anticipated 80 Complete https://irct.ir/trial/60460 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the intervention and control groups is done based on quadruple blocks in Excel software. In this software, the intervention and control groups are placed alternately. In the next column, there are quadruple blocks. At the end, the random digits created by the software RND0 function are placed. We then arrange the numbers based on block columns and random values, Blinding description: In this study, clinical caregiver will not aware about prescription drugs. 3 COVID-19 disease. Intervention 1: Intervention group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy. Then, patients receive 80 mg cinnora ampule, subcutaneously (CinnaGen Company). If needed, they will receive 40 mg of cinnora after one week. Intervention 2: Control group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is No agreement has been reached between the members yet
public Khadijeh Ghavam Nezhad
Kashan University of Medical Sciences, Shahrdari Street, Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5544 3022 Khadijehghavamnezhad201999@gmail.com Kashan University of Medical Sciences scientific Khadijeh Ghavam Nezhad
Kashan University of Medical Sciences, Shahrdari Street, Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5544 3022 Khadijehghavamnezhad201999@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years Patients with definitive diagnosis of COVID-19 18 years no limit Female Patients who treated with tumour necrosis factor α inhibitors due to previous inflammatory diseases. Positive purified protein derivative skin test. Active bacterial infection. B34.2 Coronavirus infection, unspecified Treatment - Drugs N/A Intervention group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy. Then, patients receive 80 mg cinnora ampule, subcutaneously (CinnaGen Company). If needed, they will receive 40 mg of cinnora after one week. Control group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy. Improvement of clinical symptoms (arterial oxygen). Timepoint: Daily evaluation of clinical signs for up to two weeks. Method of measurement: Pulse oximeter. C-reactive protein (CRP). Timepoint: Daily evaluation of clinical signs for up to two weeks. Method of measurement: CRP kit. Kashan University of Medical Sciences Approved 2021-12-06 Ethical Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Shahrdari Street, Kashan Kashan Isfehan Iran (Islamic Republic of)