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IRCT20131129015584N4 IRCT 2021-04-04 Mazandaran University of Medical Sciences The effect of Padzahr tablets on the symptoms of COVID-19 The effect of Persian Medicine Formula (Padzahr) on clinical manifestations of patients with COVID-19 2021-04-21 anticipated 68 Complete https://irct.ir/trial/55081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Before entering the intervention, each patient selected one of the 68 envelopes containing the codes 0001 to 0068, which was already randomly determined for each code using the Block randomization statistical software output table for each intervention group. Or assigned control. The participants will be assigned to the intervention groups in 17 blocks of 4 in a ratio of one to one (1: 1 Allocation) in order of allocation. 2-3 COVID-19. Intervention 1: Intervention group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours) + Padzahr tablets (made by NIAK with license number 0385-94-S): 2 pieces, after meals (three times a day). Intervention 2: Control group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours). Yes - There is a plan to make this available What will be shared: After the publication of the article, the results and how to perform the intervention will be shared When: After the publication of the article To whom: All academic people Conditions: After the publication of the article and for other studies and therapeutic use Where to obtain: The person responsible for scientific accountability How to obtain: Communication with the person responsible for scientific accountability Comments:
public Assie Jokar
Khazar Blvd.
Sari Iran (Islamic Republic of) 4814878787 +98 11 3324 3117 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Assie Jokar
Khazar Blvd.
Sari Iran (Islamic Republic of) 4814878787 +98 11 3324 3117 a.jokar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Probable diagnosis of COVID-19 based on national Iranian protocol 18 years 75 years Both Late 5 days from the onset of symptoms Existence of comorbidity Pregnancy and lactation history of Allergy Complicated with bacterial infection U07.1 COVID-19 Treatment - Drugs N/A Intervention group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours) + Padzahr tablets (made by NIAK with license number 0385-94-S): 2 pieces, after meals (three times a day). Control group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours) Fever reduction time. Timepoint: Time to start reducing fever after the intervention. Method of measurement: hour. Fever intensity. Timepoint: All days of hospitalization. Method of measurement: C. Blood oxygen saturation. Timepoint: All days after the intervention. Method of measurement: Pulse oximetry. Duration of hospital stay. Timepoint: Patient discharge time. Method of measurement: day. Mazandaran University of Medical Sciences Approved 2021-02-24 Ethics committee of Mazandaran University of Medical Sciences Moallem square Sari Mazandaran Iran (Islamic Republic of)