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IRCT20230116057135N2 IRCT 2023-04-05 Hamedan University of Medical Sciences NBS powder effect on the mortality rate of patients with covid-19 NBS-Covid Investigating the effect of Nutrition Bio-Shield (NBS) herbal powder on inflammatory laboratory parameters and its effect on the mortality rate of patients with covid-19 2023-04-04 anticipated 400 Complete https://irct.ir/trial/69296 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are divided into intervention and control groups by random block method. Allocation of the samples to two groups with random permutation block design will be two treatments with blocks of four. In this way, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the alternating combinations of the letters A, A, B, and B, which are 6 different combinations, on 6 cards in this order: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then a digit is randomly selected from 1 to 6. and continue this process until the sample volume reaches the quorum, Blinding description: In this study patients, researchers and data analysts don't know which group of patients will use the NBS. Physician and clinicians team, due to the prevention of possible side effects in order to consume this product, know about the group who use the powder.‎. 3 Covid-19. Intervention 1: Intervention group: Patients in the intervention group, in addition to the standard treatment panel, receive Nutrition Bio-Shield (NBS) powder as follows: the amount of NBS 500 mg capsule is 4.5 g daily in three doses: 1.5 g in the Morning, 1.5 g in the Afternoon, and 1.5 g Night, 14 days. Intervention 2: Control group: In addition to the standard treatment regimen, patients in the control group also receive placebo capsules that are given in the morning, noon, and night. 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 further information.
public Mehrdad Mosadegh
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۸۶۴۵۱۳ +98 935 563 3390 m-mosadegh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mehrdad Mosadegh
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۸۶۴۵۱۳ +98 935 563 3390 m-mosadegh@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 20 years old Corona patients based on clinical symptoms, Computerized Tomography (CT) scan and laboratory tests such as Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP), Creatine Phosphokinase (CPK), Lactate Dehydrogenase (LDH), D-Dimer and finally Polymerase Chain Reaction (PCR) confirmation test for the presence of the infectious agent. 20 years no limit Both The patient's withdrawal from the study Patients with any other chronic disease such as diabetes, cardiovascular disease, etc. Patients who have received supplements of vitamin D, zinc, B vitamins and other micronutrients in the last month. Pregnant and lactating mothers Use of corticosteroids and immunosuppressive drugs Observing any drug sensitivity (especially digestive sensitivity to gluten) as determined by the attending physician Deterioration of the patient's clinical symptoms due to the consumption of NBS powder, as determined by the attending physician Patient's death during common and selective treatments (in case of death, the patient's information is fully recorded and laboratory tests are performed along with other samples to determine the possible effect of the drug on the patient's death) U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Patients in the intervention group, in addition to the standard treatment panel, receive Nutrition Bio-Shield (NBS) powder as follows: the amount of NBS 500 mg capsule is 4.5 g daily in three doses: 1.5 g in the Morning, 1.5 g in the Afternoon, and 1.5 g Night, 14 days. Control group: In addition to the standard treatment regimen, patients in the control group also receive placebo capsules that are given in the morning, noon, and night. Measurement of inflammatory factors. Timepoint: Before the start of the intervention, after the completion of the intervention. Method of measurement: Gold standard methods (ESR test by Westergren method, CRP test by Electrochemical Immunoassay method, D-Dimer test by latex rapid kit method). Measurement of white blood cells. Timepoint: Before the start of the intervention, after the completion of the intervention. Method of measurement: Cell Counter. Mortality Rate. Timepoint: After the completion of the intervention. Method of measurement: Checking the patient's vital signs. Hamedan University of Medical Sciences Approved 2023-03-04 Research Ethics Committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh St., Qaem Sq. Hamadan Hamadan Iran (Islamic Republic of)