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Comparison effect of N-Chromosome royal jelly, propolis, and mixed honey supplementation on clinical and laboratory findings of COVID-19 patients with standard treatment: a randomized clinical trial

Protocol summary

Study aim
Comparison effect of N-chromosome royal jelly, propolis and mixed honey supplementation on clinical and laboratory findings of COVID-19 patients with standard treatment: a randomized clinical trial
Design
Two arm parallel group randomized trial, randomization will be done using the table of random numbers for 60 admitted patients of confirmed COVID-19 in Masih Daneshvari Hospital from May 2020. Thirty patients will enrolled in case group and 30 ones in control group.
Settings and conduct
This study will be performed in Masih Danesvari hospital,Tehran, Iran. 60 covid-19 confirmed patients based on inclusion and exclusion criteria will be divided into two groups (30 in each group) by simple randomization. Patients in control group will be prescribed standard regimen for COVID-19. Patients in experimental group will be prescribed royal jelly, propois and mixed honey (2 teaspoons of each one, twice a day) for one month and standard regimen for COVID-19. The routine lab data, clinical symptoms and hospitalization period, will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Age 18 to 90 years -No clear psychiatric disorder -Cooperation for medication use -No more than 48 hours have elapsed since admission. Exclusion criteria: -Any history of allergies or allergies to honey compounds -Taking warfarin
Intervention groups
The case group will be given three products including N-chromosome royal jelly, propolis, and a mixed honey (2 teaspoons of each one, twice a day )with their standard drug treatment for COVID-19. The control group will receive only standard treatment.
Main outcome variables
laboratory findings ( ESR,CRP,WBC,Ferritin, Neutophil, Lymphocyte) , clinical conditions(dyspnea class), cytokine level (IL-6)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200209046427N1
Registration date: 2020-06-07, 1399/03/18
Registration timing: registered_while_recruiting

Last update: 2020-06-07, 1399/03/18
Update count: 0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Shadi Shafaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2522
Email address
shafaghishadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of N-Chromosome royal jelly, propolis, and mixed honey supplementation on clinical and laboratory findings of COVID-19 patients with standard treatment: a randomized clinical trial
Public title
Effect of bee products on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to 90 year old without any psychological problem drug consumption compliance hospital admission during recent 48 hours
Exclusion criteria:
Allergy to honey products warfarin usage
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
-Simple randomization -Individual rabdomization -By using table of random numbers
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 Univercity of Medical Sciences, Masih Daneshvari Hospital (NRITL
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.048

Health conditions studied

1

Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.2
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Dyspnea grade
Timepoint
Dyspnea grade before intervention and daily after starting the intervention
Method of measurement
dyspnea grading according to New York heart association classification

2

Description
white blood cells (WBC) count
Timepoint
lab test before intervention and 3, and 7 days after intervention
Method of measurement
lab data assessment by blood sample

3

Description
Neutrophil to Lymphocyte count
Timepoint
lab test before intervention and 3, and 7 days after intervention
Method of measurement
lab data assessment by blood sample

4

Description
Interleukin-6 (IL-6) Level
Timepoint
lab test before intervention and 3, and 7 days after intervention
Method of measurement
lab data assessment by blood sample

5

Description
Anti SARS-Cov-2 IgG Level
Timepoint
one month after intervention
Method of measurement
blood sample

6

Description
C-reactive protein (CRP) level
Timepoint
lab test before intervention and 3, and 7 days after intervention
Method of measurement
lab data assessment by blood sample

Secondary outcomes

1

Description
duration of hospital stay
Timepoint
duration of hospitalisation
Method of measurement
Hospital records

Intervention groups

1

Description
Control group: Standared treatment for COVID-19 according to hospital protocol for admitted patients
Category
Treatment - Drugs

2

Description
Intervention group: The case group will be given three products including N-chromosome royal jelly (Caspian Apiaries Company), propolis (Caspian Apiaries Company), and a mixed honey (Caspian Apiaries Company). They should use one teaspoon of each of them, twice a day with water or milk or fruit juice.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Shadi Shafaghi
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2522
Email
pr.nritld@sbmu.ac.ir
Web page address
http://nritld.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
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Web page address
http://en.sbmu.ac.ir/index.jsp?siteid=256&fkeyid=&siteid=24&pageid=13079&siteid=256
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
Shadi Shafaghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2522
Fax
Email
shafaghishadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Shafaghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2522
Fax
Email
shafaghishadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Shafaghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2522
Fax
Email
shafaghishadi@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
all collected deidentified patient`s documents can be available.
When the data will become available and for how long
documents files will become available 6 months after publication up to one year
To whom data/document is available
Documents would be available for people working in academic institutions and people working in businesses after applying to receive it.
Under which criteria data/document could be used
Documents would be available according to cause of request.
From where data/document is obtainable
shafaghishadi@yahoo.com
What processes are involved for a request to access data/document
It is necessary for the applicant to send an e-mail to the researcher and write the reason for requesting access to the data. If confirmed, the information will be sent within a week.
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