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Investigating the effect of barely-based traditional remedy on controlling of clinical symptoms and paraclinical results in hospitalized patients with COVID-19

Protocol summary

Study aim
Evaluating the effect of barley-based product on controlling the symptoms of hospitalized patients with COVID-19 and the recovery process
Design
Randomized parallel clinical trial with control group, phase 3, design of 60 patients, random allocation software was used for randomization.
Settings and conduct
Sixty hospitalized patients with a positive nasopharyngeal PCR test or a suspected chest CT scan are randomly assigned to one of the two groups of barley-based remedy or control. Patients in the intervention group, in addition to the usual treatments, receive a glass of barley-based remedy twice a day for 5 days. The consequences of the study, including laboratory results, clinical signs, and chest x-rays, are measured daily for 5 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirming informed consent and Positive Nasopharyngeal RT-PCR Test or CT Chest Exclusion criteria: Intubated or hospitalized patient in ICU, pregnant and lactating women, diabetic patients, patients treated with corticosteroids or immunosuppressive drugs, patients undergoing dialysis, use of herbal medicines or other traditional and complementary medicine methods
Intervention groups
Intervention group: Receiving conventional medicine and receiving barley-based remedy for 5 days twice a day and one glass each time Control group: Receiving common medicine drugs
Main outcome variables
Laboratory results (number of lymphocytes, CRP), clinical symptoms (fever, cough, myalgia, shortness of breath, chills) Chest x-ray

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180923041093N6
Registration date: 2020-06-11, 1399/03/22
Registration timing: registered_while_recruiting

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-13, 1399/02/24
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of barely-based traditional remedy on controlling of clinical symptoms and paraclinical results in hospitalized patients with COVID-19
Public title
The efficacy of barely-based traditional remedy on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from COVID-19 based on Positive nasopharyngeal RT-PCR test or CT of the chest 18 years old or more Informed consent
Exclusion criteria:
Intubated patient or hospitalized in the ICU Pregnant and lactating women Diabetes Patients treated with corticosteroids or immunosuppressive drugs Use of herbal medicines or other traditional and complementary medicine methods Dialysis
Age
From 18 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
Patients will be selected according to the inclusion criteria and then randomly assigned to the experimental and control groups according to the random sequence obtained through random allocation software (random blocking method with 4 blocks).
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 Shahid Beheshti University of Medical Sciences
Street address
Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.074

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Tempreture
Timepoint
Daily
Method of measurement
Thermometer

2

Description
Cough
Timepoint
Daily
Method of measurement
Fisman scale

3

Description
Respiratory rate
Timepoint
Daily
Method of measurement
Counting the number of breaths per minute

4

Description
Weakness
Timepoint
Daily
Method of measurement
Visual analog scale

5

Description
Muscular pain
Timepoint
Daily
Method of measurement
Visual analog scale

6

Description
C Reactive Protein (CRP)
Timepoint
Daily
Method of measurement
Blood test

7

Description
Lymphocyte count
Timepoint
Daily
Method of measurement
Blood test

8

Description
O2 Saturation percentage (SpO2)
Timepoint
Daily
Method of measurement
Pulse oximetery

9

Description
Chest X ray
Timepoint
Daily
Method of measurement
Analysis of radiography

Secondary outcomes

1

Description
Number of admission days
Timepoint
Daily
Method of measurement
Counting admission days

2

Description
Mortality
Timepoint
Daily
Method of measurement
The ratio of death to total patients in each group

3

Description
Adverse effect
Timepoint
Daily
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: They receive both usual treatments (Fifth Edition of the Novel Corona Virus Guidelines: hydroxychloroquine/chloroquine phosphate with or without lopinavir/ritonavir or atazanavir/ritonavir) and barley-based remedy (water extract of barely, jujube and lasura) 200 cc, two times a day for 5 days.
Category
Treatment - Drugs

2

Description
Control group: They receive only usual treatments based on classical medicine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Mofateh
Full name of responsible person
Roshanak Mokaberinejad
Street address
Faculty of Traditional Medicine, Shams Alley, opposite Tavanir St, above Saei Park, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8877 3521
Email
mokaberi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital، Shahid Arabi street, Velenjak, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Roshanak Mokaberinejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, opposite Tavanir St, above Saei Park, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8877 3521
Email
mokaberi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmood Khodadoost
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 8, Shams Alley, Opposite Tavanir, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
mkhodadoost@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, opposite Tavanir St, above Saei Park, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8877 3521
Email
mokaberi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After completion of the study, information on the main outcome will be shared
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Data and results will be available to all researchers for corona research.
From where data/document is obtainable
Email to mokaberi@sbmu.ac.ir
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.
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