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IRCT20081019001369N2 IRCT 2020-04-07 Mashhad University of Medical Sciences Effect of berberine on COVID-19 Clinical trial of berberine against COVID-19 2020-04-20 anticipated 40 Complete https://irct.ir/trial/46868 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in three stages: 1- Random sequence generation: this step simple or limited randomization will be done based on a table of random numbers 2- Allocation concealment: which is done in the form of coded boxes (numbered drug containers) with a random sequence. In this method, a number of boxes with the same shape and size are numbered based on random sequences and contain drugs or placebo that have a completely similar appearance. 3- Execution of random allocation process: A: Identify the person who creates the random sequence B: A person who evaluates and registers researchers in terms of inclusion and exclusion criteria C: The person who assigned the participants to the groups: infectious diseases specialist The main researcher of the project, who creates a random sequence, does not interfere in other stages of randomization, including registration and allocation of participants, and the person involved in creating a random program is separate from other researchers, Blinding description: The drug and placebo are given as a same-color and –size capsules in boxes labeled with the letters A and B in box. The medical staff, the patient and the data collector are not aware of the nature of the drug or placebo, and only the executor of research project is aware of the nature of the contents of the two capsules. 2 Covid-19. Intervention 1: In addition to the standard treatment regimen for COVID-19, the berberine hydrochloride capsule (Pharmaceutical grade) 300 mg will be given three times a day for 2 weeks. Berberine capsule (300 mg) is formulated at the School of Pharmacy with the inert ingredients of aerosol and avicel. Intervention 2: Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo capsules three times a day for 2 weeks. The placebo is formulated in capsules of the same shape and size as the drug capsules and contains avicel and aerosil. 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 After the agreement of the university
public Hossein Hosseinzadeh
Blv. Vakilabad2-School of Pharmacy, 1365-91775
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1193 hosseinzadehh@mums.ac.ir Mashhad University of Medical Sciences scientific Hossein Hosseinzadeh
Blv. Vakilabad2-School of Pharmacy, 1365-91775
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1193 hosseinzadehh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with covid-19 symptoms Indication of home quarantine and outpatient medication 18 years 65 years Both Patients over 65 years of age Patients connected to a catheter or under chemotherapy Patients taking cytotoxic drugs or corticosteroids Child patients Pregnant and lactating patients Diabetic patients Patients with severe renal insufficiency as well as liver failure U07.1 COVID-19 Disease Treatment - Drugs Treatment - Drugs In addition to the standard treatment regimen for COVID-19, the berberine hydrochloride capsule (Pharmaceutical grade) 300 mg will be given three times a day for 2 weeks. Berberine capsule (300 mg) is formulated at the School of Pharmacy with the inert ingredients of aerosol and avicel. Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo capsules three times a day for 2 weeks. The placebo is formulated in capsules of the same shape and size as the drug capsules and contains avicel and aerosil. Time interval until clinical symptoms improve. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: time of recovery. Fever. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: Thermometer. Lymphopenia. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: Cell counter device. CRP. Timepoint: 3 days, 1 week and 2 weeks after treatment. Method of measurement: CRP kit. Mashhad University of Medical Sciences Approved 2020-03-31 Medical Ethics Committee of Mashhad University of Medical Sciences Blv.Vakilabad 2- School of Pharmacy-1365-91775 Mashhad Razavi Khorasan Iran (Islamic Republic of)