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IRCT20220902055856N1 IRCT 2022-09-17 Oroumia University of Medical Sciences effects of propolis in pneumonia The effect of propolis supplementation on anthropometric parameters, oxidative stress and inflammatory status, and mortality rate in patients with severe pneumonia 2022-09-23 anticipated 42 Complete https://irct.ir/trial/65668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Severe pneumonia. Intervention 1: Intervention group: This group will receive 100 mg propolis tablets bought from suren tek company twice a day for 7 days. The patient's condition and consumption of supplements will be followed up by the researcher on a daily basis. All patients will receive standard treatment for severe pneumonia, which includes parenteral antibiotics and, in certain cases, corticosteroids. If the patient does not tolerate the supplement or if an intolerable complication occurs, the patient will be excluded from the study. Intervention 2: Control group: this group will receive a placebo tablet with the same appearance characteristics as the original tablets. The duration of the placebo appointment will be 7 days, just like the main intervention of the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It requires an ethical review in terms of the possibility of publication
public Parsa Sameei
No. 66, third buali street, pole qoyun, oromiye
Oromiye Iran (Islamic Republic of) 5716616567 +98 44 3343 9215 parsa.sameei@gmail.com Oroumia University of Medical Sciences scientific Ayda esmaili
urjans street, resalat blvd, Oromiye
Oromiye Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 ph.a.esmaeili@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) the patient must be at least 18 years old and should be diagnosed with pneumonia which requires medicinal intervention pneumonia symptoms including: cough which has just started or gotten worst, purulent sputum, witnessing pneumonia-related symptoms in the chest examination, dyspnea (a breathing rate more than 20 per minute) or tachycardia, or mechanical ventilation should be seen in the first 72 hours 2 or more of the SIRS symptoms in the last 24 hours including: a body temperature below 36 or above 38, heartbeat above 90 per minute, Breathing rate above 20 per minute, or a CO2 blood concentration above 4.2 KPa, WBC>12000/mm3, OR<4000.mm3, OR>10% 18 years no limit Both ashtma allergies known rheumatological diseases acute heart failure malignancies cystic fibrosis and chronic kidney failure with a GFR below 30 ml/min hepatic failure with a C child score a history of allergy to propolis usage of any other antioxidants patients with a transplanted organ patients receiving immunosuppressive drugs pregnancy or lactation A40.3 Sepsis due to Streptococcus pneumoniae Treatment - Drugs Placebo Intervention group: This group will receive 100 mg propolis tablets bought from suren tek company twice a day for 7 days. The patient's condition and consumption of supplements will be followed up by the researcher on a daily basis. All patients will receive standard treatment for severe pneumonia, which includes parenteral antibiotics and, in certain cases, corticosteroids. If the patient does not tolerate the supplement or if an intolerable complication occurs, the patient will be excluded from the study. Control group: this group will receive a placebo tablet with the same appearance characteristics as the original tablets. The duration of the placebo appointment will be 7 days, just like the main intervention of the study. Measuring the ESR parameter (erythrocyte sedimentation rate). Timepoint: At the beginning of the study and also 7 days after the start of the intervention. Method of measurement: ESR: will be measured by observing. CRP (C reactive protein) levels. Timepoint: At the beginning of the study and also 7 days after the start of the intervention. Method of measurement: CRP: will be measured with special kits. Measuring MDA levels (malondialdehyde). Timepoint: At the beginning of the study and also 7 days after the start of the intervention. Method of measurement: by MDA kits purchased from Padgine Teb Co. Measuring TAC levels (Total antioxidant capacity). Timepoint: At the beginning of the study and also 7 days after the start of the intervention. Method of measurement: by TCA kits purchased from Padgine Teb Co. WBC changes (White blood cells). Timepoint: At the beginning of the study and also 7 days after the start of the intervention. Method of measurement: by cell counter device. Reducing the length of hospitalization. Timepoint: From admission to discharge. Method of measurement: Based on the date of admission and discharge recorded in the patient's file. Oroumia University of Medical Sciences Approved 2022-08-24 Ethics Committee of Urmia University of Medical Sciences Urjans street, Resalat blvd, Oromiye Oroumieh West Azarbaijan Iran (Islamic Republic of)