Clinical trial of the effect of crocetin in improving the clinical and laboratory symptoms of patients with COVID-19

Evaluation the effect of crocetin in improving the clinical and laboratory symptoms of patients with COVID-19

A randomized, blinded, placebo-controlled clinical trial with a parallel-group design of 40 patients, randomizing with the table of random numbers.

This study will be performed on outpatients. In this study, 40 patients with COVID-19 disease were selected and randomly assigned to two groups of 20 individuals. Patients in the standard diet control group will receive standard coronavirus treatment with a placebo. In addition to the standard diet, patients in the treatment group will be treated with 7.5 mg of crocetin three times a day for at least 2 weeks. Patients are monitored at intervals of 3 days, 1 week and 2 weeks after receiving the drug or placebo in terms of time interval until clinical and laboratory symptoms improve.

People over 18 years of age with a diagnosis of coronavirus based on clinical and laboratory symptoms; home quarantine and outpatients

The control group receives standard anti-coronavirus drugs with placebo. In addition to the common anti coronavirus drugs, the treatment group also receives crocetin capsules.

Time interval until lymphopenia improves Time interval until CRP normalizes Time interval until clinical symptoms improve (fever, cough, and myalgia)

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.

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 the research project is aware of the nature of the contents of the two capsules.