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Investigating the effect of Medical Beer on the fever of patients with COVID-19

Protocol summary

Study aim
Evaluation of the therapeutic effect of medical beer on the fever of patients with COVID-19
Design
Randomized non-blinded clinical trial, with a sample size of 60, Phase 3 Clinical trial
Settings and conduct
The location of the project is Amin Hospital in Isfahan and the study will be performed as an A Randomized Clinical Trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 18 to 70 years with inpatient clinical criteria (fever ≥ 38% or severe cough or shortness of breath or respiratory rate ≥ 24 per minute or oxygen saturation <93%), positive PCR, lung involvement in the chest CT scan. It should be noted that some patients are admitted with clinical symptoms and without a positive corona test, but this study will only be performed on those who have a positive test. Exclusion criteria: previous COVID-19 treatment, allergy and asthma, hypertension, diabetes, pregnancy, Breastfeeding, heart failure, chronic renal failure, receiving chemotherapy, taking corticosteroids, immune system deficiency
Intervention groups
Intervention group in addition to be received the prescribed medications to treat COVID-19, they will be received 200 cc of medical beer every 4 hours for 5 days. The control group will be received only the prescribed medications according to the protocol of the Ministry of Health to treat COVID-19.
Main outcome variables
The length of hospital stay, fever, muscular pain, dry cough, shortness of breath, ESR, CRP, blood cell count, Chest X-ray, Chest CT scan

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200428047229N1
Registration date: 2020-06-27, 1399/04/07
Registration timing: registered_while_recruiting

Last update: 2020-06-27, 1399/04/07
Update count: 0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Hanieh Tahermohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 4811
Email address
dr.hmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2021-03-30, 1400/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Medical Beer on the fever of patients with COVID-19
Public title
Effect of Medical Beer on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 70 years with inpatient clinical criteria (fever ≥ 38% or severe cough or shortness of breath or respiratory rate ≥ 24 per minute or oxygen saturation <93%) Positive PCR Lung involvement in CT scan of the chest
Exclusion criteria:
Previous COVID-19 treatment Allergies and asthma High blood pressure Diabetes Pregnancy Breastfeeding Heart failure Chronic renal failure Get chemotherapy Get Corticostroids Immune deficiency Patient request Need to be admitted to the ICU
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first due to the inclusion criteria, infectious diseases specialist diagnosis and positive PCR test, Patients will be selected and then randomly assigned to the experimental and control groups according to the random sequence obtained through random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.MUI.MED.REC.1399.078

Health conditions studied

1

Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
fever
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer
Method of measurement
Mercury thermometer (oral)

Secondary outcomes

1

Description
Muscular pain
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer
Method of measurement
By asking the patient and the Visual Analog Scale (VAS) score

2

Description
Dry cough
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer
Method of measurement
By asking the patient

3

Description
Dyspnea
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer
Method of measurement
By asking the patient

4

Description
ESR
Timepoint
At the beginning of the study (before the start of the intervention) and on day 5 after the start of the medical beer
Method of measurement
Sed rate device

5

Description
CRP
Timepoint
At the beginning of the study (before the start of the intervention) and on day 5 after the start of the medical beer
Method of measurement
Agglutination kit

6

Description
Blood cell count
Timepoint
At the beginning of the study (before the start of the intervention) and on day 5 after the start of the medical beer
Method of measurement
Cell Counter device

7

Description
Chest X-ray
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the medical beer
Method of measurement
Radiology set

8

Description
Chest CT scan
Timepoint
At the beginning of the study (before the start of the intervention) and on day 5, if requested by the treating physician, it will be recorded.
Method of measurement
CT scan set

Intervention groups

1

Description
Intervention group: Patients in this group receive the treatment of COVID-19 according to the protocol of the Ministry of Health, in addition they should recieve daily a glass of medical bear (200 CC) every 4 hours for 5 days.This medicine has no chemical composition and is not made by any factory. This medicine is prepared from barley decoction according to the previous coordination with the hospital kitchen and is provided to the patients.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group receive medication for COVID-19 according to the Ministry of Health protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Akram Izadikhah
Street address
Amin Hospital, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8198674531
Phone
+98 31 3448 4777
Email
a.izadikhah@resident.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sponsor Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
dr.hmohammadi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Tahermohammadi
Position
Assistant of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Traditional medicine specialist, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
Tansaz_mojgan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
hanieh Tahermohammadi
Position
Assistant of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publishing results in form of an article
When the data will become available and for how long
After completing the research work
To whom data/document is available
Public
Under which criteria data/document could be used
for research reasons
From where data/document is obtainable
Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
approving by responsible officer
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