The effect of propolis supplementation on anthropometric parameters, oxidative stress and inflammatory status, and mortality rate in patients with severe pneumonia

evaluating the effects of propolis administration on anthropometric parameters, oxidative stress and inflammatory status, and mortality rate in patients with severe pneumonia

A clinical trial with a control group, with a parallel intervention group, double-blind, randomized, phase 3 on 42 patients, a random sequence generation software is used for randomization.

the research will be conducted at Imam Khomeini Hospital in Urmia. People in the intervention group will receive tablets containing propolis supplement prepared by Soren Tek Company (containing100 mg of propolis extract twice a day) and people in the control group will also receive the same amount of placebo tablets. tablets containing propolis supplement and placebo will be completely similar in appearance. Only the person responsible for packing tablets containing propolis and placebo will know about the relevant codes

inclusion criteria: clinical symptoms of pneumonia like coughs that have recently started or have gotten worse, purulent sputum, witnessing pneumonia symptoms in the chest scan, dyspnea or tachypnea, mechanical ventilation, two or more of the SIRS symptoms exclusion criteria: asthma or allergies, acute heart failure phase, cystic fibrosis, malignancies, allergy to propolis, pregnancy or lactation

patients in the intervention group will receive tablets containing propolis supplement prepared by Soren Tek Company (containing 100 mg of propolis extract twice a day) and patients in the control group will also receive the same amount of placebo tablets.

Changes in oxidative stress parameters including MDA and TAC, inflammatory parameters including ESR and CRP, as well as qSOFA scores

Allocation of people in each of the study groups (supplement and placebo) will be done by "Random Allocation" software and using the block random division method (blocks of 4). Allocation concealment will be used to reduce the selection bias error. After admittion of the patient to the ward and obtaining the necessary criteria to enter the study, they are randomly assigned to sealed envelopes with unique codes generated by Random Allocation Software. The codes along with groups A and B (supplement group and placebo indicators) were generated at the beginning of the study by one of the collaborators of the project, who is not involved in any of the clinical phases of the intervention and sampling, and will remain with him until the end of the study. The presenters will remain unaware of the concept of codes and groups until the end of the study. Codes A and B are inserted on the envelopes in order to specify two separate groups. After allocating each group A envelope or B to the patient enrolled in the study, the envelope is opened and the code inside the envelope, which contains 4 numbers (for example 5372), which has no meaning and does not indicate any concept and is completely random, will be inserted on the supplement box. Patients are divided only according to the A or B code and the numbers inside the floor criteria envelope There is no classification and these codes are only used for labeling on medicine and placebo cans.

both patients and researchers do not know about the type of drug that receive (Propolis or placebo)and are blinded. placebo are prepared in the same shape, size, and color of propolis capsules. the medicine and the placebo are coded in the form of computerized randomization numbers. then they are given to the researcher and the patients.