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IRCT20160625028622N2 IRCT 2022-01-16 Qazvin University of Medical Sciences survey on the effect of antioxidant supplement on improvement of different symptom in covid-19 patient The effectiveness of dietary supplements containing antioxidant compounds on survival rate of patients with COVID-19 2022-01-20 anticipated 50 Complete https://irct.ir/trial/60751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two treatment groups A and B using the balance block method (Balance block randomization), the size of each block is 10 and the total number of blocks is 5 as described in the attached table. block identifier block size sequence within block treatment 1 10 1 Group B 1 10 2 Group B 1 10 3 Group B 1 10 4 Group B 1 10 5 Group A 1 10 6 Group A 1 10 7 Group A 1 10 8 Group A 1 10 9 Group A 1 10 10 Group B 2 10 1 Group B 2 10 2 Group A 2 10 3 Group A 2 10 4 Group A 2 10 5 Group B 2 10 6 Group A 2 10 7 Group B 2 10 8 Group A 2 10 9 Group B 2 10 10 Group B 3 10 1 Group A 3 10 2 Group A 3 10 3 Group B 3 10 4 Group B 3 10 5 Group A 3 10 6 Group A 3 10 7 Group A 3 10 8 Group B 3 10 9 Group B 3 10 10 Group B 4 10 1 Group A 4 10 2 Group A 4 10 3 Group A 4 10 4 Group B 4 10 5 Group B 4 10 6 Group A 4 10 7 Group B 4 10 8 Group A 4 10 9 Group B 4 10 10 Group B 5 10 1 Group B 5 10 2 Group B 5 10 3 Group B 5 10 4 Group A 5 10 5 Group A 5 10 6 Group A 5 10 7 Group B 5 10 8 Group B 5 10 9 Group A 5 10 10 Group A, Blinding description: Complementary therapy and placebo are delivered to the hospital doctor in two cans of medicine with different codes. The doctor does not know the contents of these cans and only based on the defined codes, the researcher informed them. 2 Covid-19. Intervention 1: Antioxidant supplement,Antioxidant supplement, this study is a clinical trial study. Initially, capsules containing defined doses of antioxidant compounds are formulated with the formulation and based on related studies in a pharmaceutical laboratory located in Tehran province, a pharmacologist prepares, manufactures and quality controls. This capsule contains 250 mg of vitamin C, 300 mg of N-acetylcysteine, 2.5 mg of melatonin, 100 mg of selenium, 200 mg of glutathione and 60 mg of vitamin E and 5 mg of zinc. These supplements are purchased commercially from reputable companies active in this field in higher quantities by calculating the required amount according to their defined formulation and taking into account the number of patients, and the capsules are prepared, packaged and prepared in the pharmaceutical company. Target groups will receive two supplements / placebo on the first day and one every day for 10 days in the coming days. First, the informed consent form will be delivered to all patients and written consent will be obtained from them. Intervention 2: Placebo,Placebo, this group of patients with Covid 19 (Non-Critical) who will receive routine drugs of the country's treatment protocol and will receive two placebo on the first day and one every day for 10 days in the coming days. Patients will be imaged before treatment begins. 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 There is no more information
public Dr Ehsan Aali
Bahonar Street
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6001 en.aali@gmail.com Qazvin University of Medical Sciences scientific Abbas Alami
Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6001 allami9@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) A positive PCR test for a new coronavirus Having an involvement in a CT scan of the lungs and a definitive diagnosis by the treating physician that the person is infected Therefore, people whose confirmed results of this virus are confirmed and who have 2 or more of the following symptoms will be studied in the following study: Including: Patients with pulmonary involvement of 50% and above (severe cases) (sometimes closed At the discretion of the physician and the patient's condition, lower lung involvement is also a criterion for hospitalization (moderate cases), 90 <O2 saturation <94 (moderate to severe cases) and o2 saturation <90 (severe cases), sub-cough symptoms (visual assessment criteria) Sore throat (patient report), headache (patient report), nasal congestion (patient report), fever (temperature above 37.3), body aches and pains (patient report), fatigue (patient report) 18 years 70 years Both Patients suspected of having a bacterial respiratory infection at the beginning of the study Patients with serious chronic diseases. Pregnant women Patients with HIV Patients with cancer Patients with vascular disease Patient with endocrine disease Patients who become infected during studying U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Antioxidant supplement,Antioxidant supplement, this study is a clinical trial study. Initially, capsules containing defined doses of antioxidant compounds are formulated with the formulation and based on related studies in a pharmaceutical laboratory located in Tehran province, a pharmacologist prepares, manufactures and quality controls. This capsule contains 250 mg of vitamin C, 300 mg of N-acetylcysteine, 2.5 mg of melatonin, 100 mg of selenium, 200 mg of glutathione and 60 mg of vitamin E and 5 mg of zinc. These supplements are purchased commercially from reputable companies active in this field in higher quantities by calculating the required amount according to their defined formulation and taking into account the number of patients, and the capsules are prepared, packaged and prepared in the pharmaceutical company. Target groups will receive two supplements / placebo on the first day and one every day for 10 days in the coming days. First, the informed consent form will be delivered to all patients and written consent will be obtained from them. Placebo,Placebo, this group of patients with Covid 19 (Non-Critical) who will receive routine drugs of the country's treatment protocol and will receive two placebo on the first day and one every day for 10 days in the coming days. Patients will be imaged before treatment begins. Cough. Timepoint: At the beginning of the study, 14 and 28 days. Method of measurement: frequency and severity. Chest pain. Timepoint: At the beginning of the study, 14 days. Method of measurement: presence or absence. Shortness of breath. Timepoint: At the beginning of the study, 14 days. Method of measurement: presence or absence. O2 saturation level. Timepoint: At the beginning of the study, 14 days. Method of measurement: Oxygen level (O2 Saturation) with device. Number of days with tachypnea. Timepoint: At the beginning of the study, 14 days. Method of measurement: Breathe more than 12-20 times a minute. Fever. Timepoint: At the beginning of the study, 14 days. Method of measurement: Temperatures above 37.3, with an accuracy of 6 hours. Fibrinogen levels. Timepoint: At the beginning of the study, 14 days. Method of measurement: Diagnostic laboratory. Di-dimer. Timepoint: At the beginning of the study, 14 days. Method of measurement: Diagnostic laboratory. ROS. Timepoint: At the beginning of the study, 14 days. Method of measurement: Diagnostic laboratory. Laboratory indicators. Timepoint: At the beginning of the study, 14 days. Method of measurement: Diagnostic laboratory. Duration of possible need for use of mechanical lung ventilation systems. Timepoint: At the beginning of the study, 14 days. Method of measurement: Duration of possible need for use of mechanical lung ventilation systems. Survival rate of patients. Timepoint: At the beginning of the study, 14 and 28 days. Method of measurement: Duration of clearance and mortality 28 days. Qazvin University of Medical Sciences Approved 2021-12-18 Ethics committee of ًQazvin University of Medical Sciences Bahonar street, qazvin university of medical science qazvin qazvin Ireland