Comparison of the Effect of Alcoholic Extract of Licorice Root and Placebo Capsule on Alpha Tumor Necrosis Factor (TNF-α) Inflammatory Factor Interleukin-6 (IL-6) and Inflammatory Factor 1-Beta (IL-1β) in Patients with Covid-19
Determining the effect of licorice root extract on clinical and laboratory symptoms of patients with Covid-19
Design
This study was designed as a double-blind randomized controlled clinical trial (RCT) with placebo.
Settings and conduct
120 samples are selected use blood sampling referred to the affiliated hospitals of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Includes people with laboratory confirmation of Covid virus 19
Age over 15 years
Exclusion criteria
Patient request to leave the study for any reason
Request the treating physician to exclude the patient from the study for any reason
History of drug allergies
Patients with hypertension
Group of patients with underlying disease
Intervention groups
Alcoholic extract of licorice root will be purchased from Shirin Daroo Company and will be received in sterile packages. Prior to purchase, the manufacturer will receive a Certificate of Sale and Good Manufacturing Practice. The sample will be sent to Zarband Pharmaceutical Company before the final order for glycyrrhizin content analysis and microbial testing, and the result of the analysis will be received. Alcoholic extract of licorice will be obtained from Shirin Daroo company along with COA product analysis sheet. Then a sample of it will be sent to Zardband Pharmaceutical Company for confirmation of the mentioned parameters and final approval according to the standards mentioned in international pharmacopoeias.
The microcrystalline cellulose compound under the brand name AVICEL (particle diameter: less than 50 micrometers) will be purchased as a placebo from the pharmaceutical company (Exir, Iran).
Main outcome variables
Interleukin-six (IL-6), interleukin-one beta (IL-1β), tumor necrosis factor-alpha (TNF-α), fibrinogen, d-dimer, ferritin, International Normalized Ratio (INR), reaction protein C(CRP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201111049348N1
Registration date:2021-01-03, 1399/10/14
Registration timing:prospective
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Shokoofe Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2570
Email address
shnoori@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-29, 1399/11/10
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Alcoholic Extract of Licorice Root and Placebo Capsule on Alpha Tumor Necrosis Factor (TNF-α) Inflammatory Factor Interleukin-6 (IL-6) and Inflammatory Factor 1-Beta (IL-1β) in Patients with Covid-19
Public title
The Effect of Licorice Root Extract on the Treatment of Patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes people with laboratory confirmation of Quid 19 virus regardless of clinical signs and close association
Age over 15 years
Exclusion criteria:
Patient request to leave the study for any reason
Request the treating physician to exclude the patient from the study for any reason
History of drug allergies
History of allergies
Patients with immunodeficiency
Patients with hypertension
Group of patients with underlying disease
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
2
Blood samples are taken on the first day before the intervention and on the tenth day after the intervention for the main and routine variables of the study.
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the law of random allocation has been used. Thus, in the above study, with a sample size of 120 people, 60 balls for the intervention group (consumers of capsules containing licorice extract) with the title A and 60 balls for the control group (users of placebo capsules) with the title B were placed in a lottery container. And then randomly for each patient the balls are taken out of the container without replacement and the sequence created for each patient is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because the capsule containing licorice extract and the placebo are exactly the same color and size, patients and the research team are unaware of its contents, and only the treating physician knows which patient has taken which capsule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak Daneshjo Boulevard Kodakyar Alley
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.585
Health conditions studied
1
Description of health condition studied
People with COVID 19 whose disease has been confirmed by Real Time PCR
ICD-10 code
ICD-10 code description
U07.1
Primary outcomes
1
Description
Interleukin 6( IL-6)
Timepoint
Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention
Method of measurement
Using the kit
2
Description
Interleukin One Beta( IL-1β)
Timepoint
Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention
Method of measurement
Using the kit
3
Description
Alpha tumor necrosis factor(TNF-α)
Timepoint
Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention
Method of measurement
Using the kit
Secondary outcomes
1
Description
The international normalized ratio (INR)
Timepoint
Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study.
Method of measurement
Through a clinical laboratory
2
Description
D -Dimmer
Timepoint
Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study.
Method of measurement
Through a clinical laboratory
3
Description
Fibrinogen
Timepoint
Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study.
Method of measurement
Through a clinical laboratory
4
Description
Ferritin
Timepoint
Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study.
Method of measurement
Through a clinical laboratory
5
Description
C Reactive Protein (CRP)
Timepoint
Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study.
Method of measurement
Through a clinical laboratory
Intervention groups
1
Description
Consumption of capsules containing licorice extract in the intervention group.Alcoholic extract of licorice root will be purchased from Shirin Daroo Company and will be received in sterile packages. Prior to purchase, the manufacturer will receive a Certificate of Sale and Good Manufacturing Practice. The received sample will be sent to Zarband Pharmaceutical Company before the final order for glycyrrhizin content analysis and microbial test and the result of the analysis will be received. Alcoholic extract of licorice will be obtained from Shirin Daroo company along with COA product analysis sheet.Then, the sample will be sent to Zardband Pharmaceutical Company for confirmation of the mentioned parameters and final approval according to the standards mentioned in international pharmacopoeias. The extract will be added and mixed thoroughly. The powder obtained in the pharmaceutical factory (Osweh, Iran) will be packaged in an orange gelatin capsule (400 mg) and in a brown opaque can. Capsules containing licorice extract will be taken for one month in the amount of one capsule the day after lunch with a glass of water.
Category
Placebo
2
Description
Control group: Placebo in capsules with the same color and size as the drug in cans similar to capsules containing licorice. Microcrystalline cellulose composition under the brand name AVICEL (particle diameter: less than 50 micrometers) as a placebo from the pharmaceutical company (Elixir , Iran) will be purchased. Placebo capsules will be taken for one month in the amount of one capsule per day after lunch with a glass of water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Subsidiary hospitals of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Shokofe Noori
Street address
Student Boulevard, Arabi Alley
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Dr.Afshin Zarghi
Street address
Koodkiar Street, Student Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@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
Mrs Shokofe Noori
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2570
Email
shnoori85@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Shokofe Noori
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2570
Email
shnoori85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Shokofe Noori
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2570
Email
shnoori85@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because patient information is private and not available to the public
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
Patients' personal data is private and not available to the public, but the data and results of their analysis will be made available to the public.
When the data will become available and for how long
Unlimited
To whom data/document is available
public
Under which criteria data/document could be used
To improve people's knowledge about whether licorice consumption modulates the clinical symptoms of COVID 19 patients.
From where data/document is obtainable
Databases
What processes are involved for a request to access data/document