| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Patients were randomized in 1:1 allocation in two groups (group-A and group-B) which contains 50 patients"
Comment: No information on allocation sequence. No information on allocation concealment. Allocation sequence probably random. |
| Deviations from intervention |
Some concerns |
Quote: "prospective, open-label, randomized and double blind clinical trial"; "The participants of the placebo group were received a similar tablet without therapeutic effects"
Comment: Blinding unclear as no description provided and contradictory descriptions used in study. No information on cross-over (no flow chart) No information on administration of co-intervention of interest: antivirals. biologics, corticosteroids. Data analyzed appropriately; participants analyzed according to their intervention assignment. |
| Missing outcome data |
Low |
Comment:100 patients randomized; 100 patients analyzed.
Risk assessed to be low for the outcome: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unclear blinding
Mortality is observer-reported and not involving judgement. Risk assessed to be low for the outcome: Mortality. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The prospective registry was available and utilized
The mortality outcome was not listed in the registry nor in the reported as an outcome in the paper. Risk assessed to be low for the outcome: Mortality. |
| Overall risk of bias |
Some concerns |