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IRCT20211020052819N1 IRCT 2022-07-04 Artesh University of Medical Sciences Evaluation of the effect of a natural product called Capsule 4 of edible fungi based on Ganoderma, Lentinula edodes, Trametes versicolor, Grifola frondosa on clinical and laboratory symptoms, respiratory and prognosis of patients with coronavirus and monkeypox referred to the Infectious Diseases Clinic of Imam Reza Hospital in 2022 Evaluation of the effect of a natural product called Capsule 4 of edible fungi based on Ganoderma, Lentinula edodes, Trametes versicolor, Grifola frondosa on clinical and laboratory symptoms, respiratory and prognosis of patients with coronavirus and monkeypox referred to the Infectious Diseases Clinic of Imam Reza Hospital in 2022 2022-06-25 anticipated 100 Complete https://irct.ir/trial/64314 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Describe how to randomize To perform the method, random presentation (random blocks) should be used for implementation using Randome Allocation software. How to do it so that equal to the total number of patients, the sheet is considered to be divided into four equal groups and in a specific part of the top of the sheet to separate and categorize information use the letters S and I. S; Standard I: Intervention Now, with each patient's visit, we randomly remove a sheet from the drawer and give it to one of the two groups (intervention or control). Once the 4 sheets have been pulled out, completed, and returned to the drawer, we can continue this procedure until the end of the number of patients intended to complete the trial, Blinding description: Participant, Outcome assessor, Data analyser, Data and Safety Monitoring Board are masked. 3 COVID-19. Intervention 1: This study will be conducted as a three-blind randomized clinical trial for 5 days on 100 people infected with corona virus. For this purpose, 50 mild patients and 50 moderate hospitalized patients (a total of 100 patients) who have already been diagnosed with COVID-19 and monkey pox based on pulmonary involvement or positive PCR will be randomly divided into two groups (25 patients Mild along with 25 moderate patients hospitalized in the intervention group and 25 mild patients along with 25 moderate patients hospitalized in the control group). intervention group; Daily one capsule (each capsule containing 200 mg of the combination of 4 mushrooms). Supplements and placebo will be received after breakfast. For data analysis, SPSS version 22 software will be used to analyze data with a significance level of P<0.05. Intervention 2: Control group: 50 patients receiving the protocol of the Ministry of Health, the control group will take a placebo capsule (200 mg of maltodextrin in each capsule) daily for 5 days. 25 mild patients along with 25 moderate patients hospitalized in the control group. Yes - There is a plan to make this available What will be shared: Information will be considered in the publication of the article When: One year after the results are published To whom: University professors Conditions: Researchers will have access after the article is published Where to obtain: https://www.linkedin.com/in/mozhdehhaddadi/ https://www.researchgate.net/profile/Mozhdeh-Haddadi How to obtain: Sending direct messages will have access to the specialized pages of LinkedIn and Research Gate Comments:
public Mozhdeh Haddadi
Gordafarid St, Etemadzadeh St, Fatemi St
Tehran Iran (Islamic Republic of) 1411845117 +98 21 6642 7293 mozhdeh_haddadi_777@yahoo.com Artesh University of Medical Sciences scientific Mozhdeh Haddadi
Gordafarid St, Etemadzadeh St, Fatemi St
Tehran Iran (Islamic Republic of) 1411845117 +98 21 6642 7293 mozhdeh_haddadi_777@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Admission for COVID-19 patients, ranging in age from 18 to 70 years, No history for diabetes, hypertension, smoking, hypertension Positive PCR test for COVID-19 18 years 70 years Both Patients with very large lung involvement and severe general condition and should be admitted to the intensive care unit. Reluctance to continue the plan Side effects that can cause the patient to stop the plan or leave the study after taking the supplement Creating any unwanted digestive problems including heartburn, nausea, nausea, vomiting, diarrhea, etc. Any allergies, whether skin, respiratory or other Creating any side effects that did not exist before taking the supplement RA01.0 Severe Acute Respiratory Syndrome coronavirus Treatment - Drugs Treatment - Drugs This study will be conducted as a three-blind randomized clinical trial for 5 days on 100 people infected with corona virus. For this purpose, 50 mild patients and 50 moderate hospitalized patients (a total of 100 patients) who have already been diagnosed with COVID-19 and monkey pox based on pulmonary involvement or positive PCR will be randomly divided into two groups (25 patients Mild along with 25 moderate patients hospitalized in the intervention group and 25 mild patients along with 25 moderate patients hospitalized in the control group). intervention group; Daily one capsule (each capsule containing 200 mg of the combination of 4 mushrooms). Supplements and placebo will be received after breakfast. For data analysis, SPSS version 22 software will be used to analyze data with a significance level of P<0.05. Control group: 50 patients receiving the protocol of the Ministry of Health, the control group will take a placebo capsule (200 mg of maltodextrin in each capsule) daily for 5 days. 25 mild patients along with 25 moderate patients hospitalized in the control group LDH. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: blood test. CBC diff. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: blood test. Na/ k/ Ca / SGOT / SGPT / Creatine / FBS/ Urea. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: blood test. ESR1. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: blood test. CRP. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: blood test. Weakness and nausea. Timepoint: Before the intervention and 5 days after the intervention. Method of measurement: check list. Determining the effect of supplementation on the amount of oxygen. Timepoint: 5 Days. Method of measurement: Pulse oximeter. General condition of people and vitality after treatment. Timepoint: 5 Days. Method of measurement: En Examination and history. Artesh University of Medical Sciences Approved 2022-06-19 Ethics Committee of Army University of Medical Sciences Etemadzadeh St, Fatemi St Tehran Tehran Iran (Islamic Republic of)