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IRCT20201004048923N1 IRCT 2020-12-13 Tehran University of Medical Sciences Effect of biotin, brewer’s yeast and vitamin C supplements in patients with COVID-19 Investigation of simultaneous administration of biotin, brewer’s yeast, and vitamin C supplements on the improvement of clinical symptoms in patients with COVID-19 2020-10-15 anticipated 50 Complete https://irct.ir/trial/51442 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The stratification layer in this study is age. In order to allocate the same number of people in both groups, stratified randomization was used. Randomization of individuals into intervention and control groups was performed using a random number list created online by Random.org.This list is randomly divided between intervention and control groups from 1 to 50. 3 Coronavirus disease 2019 (COVID-19). Intervention 1: Intervention group: Patients in this group, addition to their routine treatment will receive; first day: two biotin tablets (5000 micrograms) simultaneously and after that with at least 6 hours, one another biotin tablet (5000 micrograms), second and third days: two biotin tablets (5,000 micrograms) with at least 8 hours interval. Fourth day up to the end of intervention: one biotin tablet (5,000 micrograms) daily. In addition to biotin, one effervescent tablet of vitamin C (500 mg) and two tablets of brewer's yeast will be received, daily up to the end of intervention. Intervention 2: Control group: Control group will receive only routine COVID-19 treatment. 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 Maliheh Paknejad
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
Tehran Iran (Islamic Republic of) 1417613151 +98 21 6405 3295 paknejadma@tums.ac.ir Tehran University of Medical Sciences scientific Dr Maliheh Paknejad
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
Tehran Iran (Islamic Republic of) 1417613151 +98 21 6405 3295 paknejadma@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 60 years old Male sex COVID-19 patients with positive chest CT scan 20 years 60 years Male Infectious diseases, cancer and autoimmune diseases Severe heart and liver diseases Existence of severe clinical symptoms that require hospitalization Diabetes U07. 1 U07. 1 Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group, addition to their routine treatment will receive; first day: two biotin tablets (5000 micrograms) simultaneously and after that with at least 6 hours, one another biotin tablet (5000 micrograms), second and third days: two biotin tablets (5,000 micrograms) with at least 8 hours interval. Fourth day up to the end of intervention: one biotin tablet (5,000 micrograms) daily. In addition to biotin, one effervescent tablet of vitamin C (500 mg) and two tablets of brewer's yeast will be received, daily up to the end of intervention. Control group: Control group will receive only routine COVID-19 treatment. Clinical symptoms improvement. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Fever. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Chills. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Fatigue. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Cough. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Shortness of breath. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Headache. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Myalgia. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Earache. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Rhinorrhea. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Sore throat. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Diarrhea. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Nausea or vomiting. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Swelling. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Skin allergy. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Paleness of the fingers and toes. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Smell or taste loss. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Chest pain or discomfort. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Loss of the ability to move or speak. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Insomnia. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Sweating. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. Anorexia. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. By researcher Approved 2020-09-30 Ethics committee of Tehran University of Medical Sciences Bulding No 1, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St Tehran Tehran Iran (Islamic Republic of)