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IRCT20190415043279N9 IRCT 2020-12-22 Sanandaj University of Medical Sciences Evaluation of the effect of Propolis COVID 19 Evaluation of the effect of Propolis on the recovery process of COVID 19 patients 2020-12-05 anticipated 72 Complete https://irct.ir/trial/52853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Propolis Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients, Blinding description: All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study. 3 Covid-19. Intervention 1: Intervention group: Propolis capsules are taken in the form of 500 mg capsules (made by Shahdineh Golha Company) twice a day for 14 days. Intervention 2: Control group: The placebo is taken as a capsule Twice a day for 14 days. 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 No more information
public Vahid Yousefinejad
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617713466 +98 87 3366 4645 hooman56y@yahoo.com Sanandaj University of Medical Sciences scientific Sabah Hasani
Kurdistan University of Medical Sciences, Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6617713466 +98 87 3366 4645 S.hasani@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) Definitive confirmation of Covid 19 based on RT-PCR results Hospitalized patients Ventilator independent patients no limit no limit Both Pregnancy Breastfeeding Type 1 diabetes Severe renal failure Metabolic acidosis Severe respiratory failure Chemotherapy recipients Taking anticoagulants U07.1 Other coronavirus as the cause of diseases classified elsewhere Placebo Placebo Intervention group: Propolis capsules are taken in the form of 500 mg capsules (made by Shahdineh Golha Company) twice a day for 14 days. Control group: The placebo is taken as a capsule Twice a day for 14 days. Fever. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Thermometer. CBC. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Cell Counter. Cough. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Muscle pain. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. C Reactive Protein. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Agglutination. Blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter. Respiratory Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: By observing the occurrence of breaths. Heart Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter. Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: ESR device. Lactate Dehydrogenase. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Autoanalyzer. CT scan findings. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: CT scan. Gastrointestinal symptoms. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Anorexia. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Loss of Smell and Taste. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Shortness of breath. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Headache. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Sore throat. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire. Body Mass Index (BMI). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: by measuring height and weight using a scale and height meter. IL-6. Timepoint: At the end of the intervention. Method of measurement: ELISA kit. Duration of hospitalization. Timepoint: Daily since hospitalization. Method of measurement: Counting the day. Need for ICU. Timepoint: Daily since hospitalization. Method of measurement: Patient's file. Need for intubation. Timepoint: Daily since hospitalization. Method of measurement: Patient's file. Sanandaj University of Medical Sciences Approved 2020-10-13 Ethics committee of Kurdistan University of Medical Sciences Pasdaran Blvd., Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)