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IRCT20090803002276N4 IRCT 2021-10-29 Arnica darou danesh adrin Evaluation of impact of Calcium Calcium Fructoborate in patients admitted with the diagnosis of COVID19 infection. Effects of organic boron - sugar complex (as Calcium Fructoborate) supplement on the severity and consequences of COVID-19 in inpatient cases: A double blind Clinical Trial 2021-11-01 anticipated 300 Complete https://irct.ir/trial/59140 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule is used for allocation of patients to intervention and control groups. one hundred fifty pieces of paper will be marked as intervention and control and placed in a bag. In the first day of admission, one of papers is pulled out randomly and according to the word written on the paper, the participant will be placed in one of the two groups. Neither the patient nor the chief researcher will be notified of their assignment to the groups, Blinding description: During the process of allocation of patients to intervention and placebo groups, only the clinical caregivers will be notified of the individual's allocation to the drug or placebo group. There is no difference between the drug and the placebo in terms of shape and taste and the patient will not notice his/her group at all. Outcome assessors also do not know to what group each patient belongs to. Statistical analysts and authors of the draft article, identify the patients only by a number and their name will remain completely unknown to them. 2-3 covid-19. Intervention 1: Intervention group: Standard therapeutic regimen for COVID-19 and a dose of 5 milliliter of a syrup containing 430 mg Calcium fructoborate solution prepared by Arnica daru Danesh Adrin Co. prescribed daily by oral route from the first day of admission to completion of ten days. Intervention 2: Control group: Standard therapeutic regimen for COVID-19 and a dose of placebo as syrup prepared by Arnica daru Danesh Adrin Co. with the same color, odour, taste and volume of the the syrup prescribed for the intervention group for daily oral use till 10 days, for patients in control group. Yes - There is a plan to make this available What will be shared: All data, after the individuals are unidentified, can be shared When: Six months after publishing the results To whom: Academic researchers Conditions: Scientific purposes Where to obtain: Website of the Research Committee of Qazvin University of Medical Sciences How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Behzad Bijani
47 Bahram Alley, Hokmabad St.
قزوین Iran (Islamic Republic of) 3145616666 +98 28 3335 4808 dr.bijani@gmail.com Qazvin University of Medical Sciences scientific Behzad Bijani
47 Bahram Alley, Hokmabad St.
Qazvin Iran (Islamic Republic of) 3415616666 +98 28 3335 4808 dr.bijani@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Admission in the hospital with a positve PCR test for COVID-19 Age between 19 and 80 years 19 years 80 years Both Patients suspected to bacterial infections in the first day of admission suffering severe chronic diseases pregnancy consumption of medications not recommended in national COVID-19 guideline. U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Standard therapeutic regimen for COVID-19 and a dose of 5 milliliter of a syrup containing 430 mg Calcium fructoborate solution prepared by Arnica daru Danesh Adrin Co. prescribed daily by oral route from the first day of admission to completion of ten days. Control group: Standard therapeutic regimen for COVID-19 and a dose of placebo as syrup prepared by Arnica daru Danesh Adrin Co. with the same color, odour, taste and volume of the the syrup prescribed for the intervention group for daily oral use till 10 days, for patients in control group. Mortality rate. Timepoint: from including to study to 30 days. Method of measurement: Observation. Hospital stay. Timepoint: After discharge. Method of measurement: Patient hospital record. َArterial Oxygen Saturation. Timepoint: Daily. Method of measurement: Pulse oxymeter device. Respiratory rate. Timepoint: Daily. Method of measurement: Counting the number of breaths per minute. Leukocyte count. Timepoint: Every three days. Method of measurement: Cell counter device. Lymphocyte percentage. Timepoint: Every three days. Method of measurement: Cell counter device. Serum electrolites. Timepoint: Every three days. Method of measurement: Flame photometer device. Quantitative C reactive Protein. Timepoint: Every three days. Method of measurement: Turbidometer device. Arnica darou danesh adrin Approved 2021-09-18 Ethics committee of Qazvin University of Medical Sciences Research deputy of Qazvin University of Medical Sciences, first alley, Maveddat St, Shaheed Beheshti Blvd Qazvin Qazvin Iran (Islamic Republic of)