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IRCT20200406046965N1 IRCT 2020-04-12 Mashhad University of Medical Sciences The effect of elderberry syrup against COVID-19 symptoms A comparison of Elderberry (Sambucus nigra) extract syrup and placebo against COVID-19 symptoms in outpatients and home quarantined patients: A randomized double-blind clinical trial 2020-04-20 anticipated 40 Complete https://irct.ir/trial/46958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization happens at three stages: 1- Random sequence generation: Simple or limited randomization will be performed based on the table of random numbers. 2- Allocation concealment: This step will be performed 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, containing either treatment drug or placebo with a completely similar appearance. 3- Execution of random allocation process: A: To 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 has assigned the participants to the groups: Infectious diseases specialist who creates a random sequence, does not interfere in other stages of randomization, including registration and allocation of participants. The person involved in creating a random program is separate from other researchers, Blinding description: The treatment drug and placebo are given as same-colored syrups with same-sized containers in boxes labeled with the letters A and B. The medical staff, the patient and the data collector are unaware of the nature of the drug or placebo and of the content of the boxes. The executor of this research project is the only person aware of the contents of boxes. 2 COVID-19 disease. Intervention 1: Intervention group:The patients will receive 10 ml of elderberry extract syrup 3 times daily (2.6 g of elderberry extract per day equivalent to 15.76 g of fresh elderberries) beside the standard treatment regimen for COVID-19 according to the Ministry of Health protocol. This treatment will continue for 2 weeks. The syrup is formulated according to the United States Pharmacopoeia description. This syrup is preservative-free and remains stable for up to 1 month. The syrups will be prepared freshly at the School of Pharmacy, Mashhad University of Medical Sciences. Intervention 2: Control group: The patients will receive the placebo syrup beside the standard treatment regimen for COVID-19 according to the Ministry of Health protocol with the same order as the intervention group.The placebo consists of USP syrup formula with food-grade coloring agents with the same shape and size containers as the elderberry syrup. This syrup is preservative-free and will be prepared freshly at the School of Pharmacy, Mashhad University of Medical Sciences. 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 Due to a recent decision by Mashhad University of Medical Sciences Research Council, the raw data and results of any clinical trial regarding COVID-19 disease should be confirmed by this council before publication.
public Seyed Ahmad Emami
School of Pharmacy, University Campus, VakilAbad boulvard
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1267 emamia@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Ahmad Emami
School of Pharmacy, University Campus, VakilAbad boulvard
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1267 emamia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) A definitive diagnosis of COVID-19 infection based on laboratory confirmation (lymphocytopenia, increased quantitative CRP, chest X-ray results) and clinical symptoms of patients including fever, coughs and myalgia Outpatients and home quarantined patients 18 years 65 years Both Hospitalization Age> 65 y and <18 y Patients with catheter Patients receiving chemotherapy drugs, corticosteroids and theophylline Autoimmunity Gastrointestinal diseases Migraine Diabetes Hypokalemia Myalgia Respiratory diseases Smoking Pregnancy and breast feeding U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group:The patients will receive 10 ml of elderberry extract syrup 3 times daily (2.6 g of elderberry extract per day equivalent to 15.76 g of fresh elderberries) beside the standard treatment regimen for COVID-19 according to the Ministry of Health protocol. This treatment will continue for 2 weeks. The syrup is formulated according to the United States Pharmacopoeia description. This syrup is preservative-free and remains stable for up to 1 month. The syrups will be prepared freshly at the School of Pharmacy, Mashhad University of Medical Sciences. Control group: The patients will receive the placebo syrup beside the standard treatment regimen for COVID-19 according to the Ministry of Health protocol with the same order as the intervention group.The placebo consists of USP syrup formula with food-grade coloring agents with the same shape and size containers as the elderberry syrup. This syrup is preservative-free and will be prepared freshly at the School of Pharmacy, Mashhad University of Medical Sciences. Fever. Timepoint: Days 3, 7 and 14 after the intervention beginning. Method of measurement: Thermometer. Shortness of breath. Timepoint: Days 3, 7 and 14 after the intervention beginning. Method of measurement: Autosaturation device, Counting the number of breaths in 1 minute. Coughs. Timepoint: Days 3, 7 and 14 after the intervention beginning. Method of measurement: Patient follow up. Myalgia. Timepoint: Days 3, 7 and 14 after the intervention beginning. Method of measurement: Patient follow up. Lymphocytopenia. Timepoint: days 3, 7 and 14 after the intervention beginning. Method of measurement: Cell counter. C-reactive protein. Timepoint: days 3, 7 and 14 after the intervention beginning. Method of measurement: CRP kit. Mashhad University of Medical Sciences Approved 2020-04-06 Medical Ethics Committee of Mashhad University of Medical Sciences School of Pharmacy, University Campus, Vakil Abad boulvard Mashhad Razavi Khorasan Iran (Islamic Republic of)