Investigating the effect of bromelain on inflammatory and immunological indicators of patients with covid-19

Investigating the effect of bromelain on inflammatory and immunological indicators of patients with covid-19

A clinical trial with a control group, parallel groups, phase 3, double-blind, and randomized on 100 patients. Randomization by random numbers table.

The present study will be a randomized clinical trial, and the tested population will be among patients infected with the new coronavirus referred to Masih Deneshvari Hospital in Tehran. Considering the inclusion criteria, patients are randomly divided into two groups. In the sample group, one Anahil capsule containing 500 mg of bromelain is prescribed to the patients every 12 hours. In the control group, placebo capsules are used exactly with the above intervals. Peripheral blood samples are taken from all patients in regular appointments according to the attached questionnaire and sent to the laboratory to check the investigated factors. The results are evaluated based on the design of the questionnaire and its completion, using the t-test and SPSS21 software.

Inclusion criteria: aged between 18-70 years, patient being alert. Exclusion criteria: lack of consent to enter the project, allergy to pineapple and bromelain drug, hospitalization in ICU, suffering from liver and kidney diseases, use of corticosteroids in the last two weeks.

In the intervention group, one Anahil capsule containing 500 mg of bromelain was prescribed to the patients every 12 hours. In the control group, placebo capsules were used with the above intervals.

WBC; lymph; Neutrophil; ESR; CRP; IL-6; TNFa

With simple randomization and using random numbers table and individual randomization unit. For randomization, we use a table that consists of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. There is no discernible pattern of numerical values. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move down row by row. For two treatments, we put numbers 0 to 4 for treatment A and numbers 5 to 9 for treatment B. The numbers in the first row of the table are as follows: 0,5,2,7,8,4,3,7,...... Now, based on the above numbers, we have the following allocation for people: A, B, A, B, B, ...

In order to prevent any possible complications, the main therapist is aware of the assignment of treatment groups. The patients participating in the study were not blinded to the treatment they received. The experts responsible for data collection and analysis are not aware of the allocation of different study groups.