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

Clinical trial of the effects of elderberry extract syrup against COVID-19 symptoms in outpatients and home quarantined patients

This is a randomized, double-blinded, placebo controlled clinical trial with a parallel group design of 40 patients. Randomization will be performed with the table of random numbers.

This study will be performed on outpatients and home quarantined patients. 40 patients with COVID-19 disease will be selected and randomly assigned to two groups of 20 individuals (Imam Reza hospital, Mashhad, Razavi Khorasan). Then the clinical symptoms and laboratory results of the patients will be monitored on days 3, 7 and 14 from the beginning of the intervention.

Inclusion criteria: People over 18 years and under 65 years old with a diagnosis of coronavirus infection based on clinical symptoms and laboratory results; home quarantined patients and outpatients. Non-inclusion criteria: Patients receiving chemotherapy drugs, diabetics, patients with gastrointestinal and respiratory diseases.

The control group receives standard anti-coronavirus drugs with placebo. The intervention group receives standard anti-coronavirus drugs with elderberry syrup.

Lymphocytopenia and clinical symptoms including fever, coughs and myalgia; CRP

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.

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.