Determination The effect of propolis supplementation on clinical manifestations and inflammatory biomarkers in patients with COVID-19
Design
Clinical trial with control group, with parallel groups, triple blind, randomized, phase 3 on 88 patients. The randomization will be based on the order of the randomization table prepared by the computer
Settings and conduct
This clinical trial will be performed on 88 patients with Covid-19 referring to the clinic of Razi Hospital in Ahvaz. Patients are treated with medication for 4 weeks according to the defined protocol. In order to blind the study, patients, physicians, and researchers are unaware of which group are taking studying drug or placebo.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years Laboratory confirmation of Covid-19 (2019-nCoV Real-Time RT-PCR)
Intervention groups
Patients in both groups receive the treatment based on the fifth version of the Covid-19 National Guidelines.Patients in the intervention group, in addition to the standard treatment protocol, receive propolis supplement in the form of 500 mg capsules twice a day for 1 month. And the control group also receives placebo according to the above method.
The effect of propolis supplementation on clinical manifestations and inflammatory biomarkers in patients with COVID-19
Public title
effect of propolis in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 65 years
Laboratory confirmation of Covid-19 (2019-nCoV Real-Time RT-PCR)
Exclusion criteria:
Pregnancy and lactation, a history of allergies to honey and bee products, uncontrolled underlying disease including neuropsychiatric problems, diabetes, thyroid disorders, heart disease, chronic liver or kidney failure, and autoimmune diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In this triple blind study, patient, physician (treatment team) and the data analyzer did not know the type of data and supplements.Allocate patients to two intervention and control groups so that the list of subjects studied will be randomly generated by a computer.The intervention and control group will be placed inside the numbered envelopes and will be sealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study patients, Physician and researcher don't know which group of patients will use the medicine placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Ahvaz
Province
Khouzestan
Postal code
631911154 061
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.ABADANUMS.REC.1399.031
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Cough
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination
2
Description
Oxygen saturation
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination
3
Description
Respiratory rate
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination
4
Description
Body temperature
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination
5
Description
LI-6
Timepoint
First and 30 days after the intervention
Method of measurement
ELISA
6
Description
TNF alpha
Timepoint
First and 30 days after the intervention
Method of measurement
ELISA
7
Description
Crp-hs
Timepoint
First and 30 days after the intervention
Method of measurement
ELISA
8
Description
CBC
Timepoint
First and 30 days after the intervention
Method of measurement
Cell counter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The propolis supplement is taken as a 500 mg capsule twice a day for 1 month
Category
Treatment - Drugs
2
Description
Control group: The placebo is taken as a capsule twice a day for 1 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Reza Malihi
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6155819953
Phone
+98 61 3555 0592
Email
r.malihi@abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Reza Malihi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Ahvaz
Province
Khouzestan
Postal code
631911154
Phone
+98 61 3555 0592
Email
r.malihi@abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Reza Malihi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
َAbadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
r.malihi@abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Reza Malihi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
r.malihi@abadanums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Since 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No other conditions are considered
From where data/document is obtainable
Email of Responsible person
What processes are involved for a request to access data/document