Effect of aqueous extarct of licorice in coronavirus outpatients
Design
Randomized, blinded, placebo controlled clinical trial. Effect of licorice capsules in 20 patients which have inclusion criteria will be evaluated. Simultanously, 20 patients will take placebo. Medicine and placebo in the same form and package with the alphabetics A and B will be deliverd to physiciana and patients. Patients must take the capsules three times a day for 14 days
Settings and conduct
Randomized, blinded, placebo controlled clinical trial will be in mashhad . effect of licorice capsules in 20 patients with coronavirus disease which have inclusion criteria will be evaluated. Simultanously 20 patients will take placebo. Medicine and placebo in the same form and package with the alphabetics A and B will be deliverd to physician and patients. The patients must take the capsules three times a day for 14 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: The outpatients in quarantine, take medicine, diagnosed for coronavirus disease according to clinic ( fever, cough, myalgia) and paraclinic parameters (lymphopenia, increase CRP). Exclusion criteria: Sensitivity to licorice and it derivatives; below 18 and above 65 years old; hepato, renal or respiratory disorders; take cytotoxic, corticosteroid drugs; nursing or pregnant women
Intervention groups
Effect of licorice capsules in 20 patients which have inclusion criteria will be evaluated. Simultanously 20 patients which have inclusion criteria will take placebo.
Main outcome variables
Time interval until lymphopenia improves
Time interval until CRP normalizes
Time interval until clinical
symptoms improve (fever, cough and myalgia)
General information
Reason for update
Acronym
LCS
IRCT registration information
IRCT registration number:IRCT20200404046933N1
Registration date:2020-04-12, 1399/01/24
Registration timing:prospective
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Gholamreza Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1191
Email address
karimig@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of aqueous extract of licorice on coronavirus outpatients: A randomized, double-blind, placebo-controlled clinical trial
Public title
Evaluation the effect of licorice for treatment of coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed for coronavirus according to clinic such as fever, cough and mylagia
Patients diagnosed for coronavirus according to paraclinic such as lymphopenia and increase of CRP
Patients in the range of 18-65 years old
Exclusion criteria:
Sensitivity to licorice and it derivatives
Patients with hepato, renal or respiratory disorders
Patients who take cytotoxic or corticosteroid drugs
Nursing or pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in three stages: 1- Generation simple or limited randomization will be done based on a table of random numbers
2- Allocation concealment: which is done in the form of
coded boxes (numbered drug containers) with a random
sequence. In this method, a number of boxes with the
same shape and size are numbered based on random
sequences and contain drugs or placebo that have a
completely similar appearance. 3- Execution of random
allocation process: A: Identify the person who creates the
random sequence B: A person who evaluates and
registers researchers in terms of inclusion and exclusion
criteria C: The person who assigned the participants to
the groups: infectious diseases specialist The main
researcher of the project, who creates a random
sequence, does not interfere in other stages of
randomization, including registration and allocation of
participants, and the person involved in creating a
random program is separate from other researchers.
Blinding (investigator's opinion)
Double blinded
Blinding description
the medicine in the form of similar capsule but with the alphabetics A or B will be delivered to physician and patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Mashhad University of Medical Sciences
Street address
Blv.Vakilabad 2- School of Pharmacy-1365-91775
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.MUMS.REC.1399.047
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19 disease
Primary outcomes
1
Description
Time interval until clinical symptoms improve
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
Time of recovery
2
Description
Lymphopenia
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
Cell counter device
3
Description
CRP level
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
CRP kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the standard treatment regimen for covid-19, capsules which have aqueous licorice extract containing 80 mg of the active ingredient glycyrrhizin will be given three times a day for 2 weeks. Licorice capsules are formulated at the Mashhad School of Pharmacy with the ineffective ingredients of Ovisil and Arozil
Category
Treatment - Drugs
2
Description
Control group: ]n addition to general drugs for treatment of corona, the patients take placebo capsule 3 times a day for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr. Dehghan Nayeri
Street address
Imam reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
DehghanMJ@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Karimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1191
Email
karimig@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Karimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil abad Blvd- pharmacy school
City
Mashhad
Province
Razavi Khorasan
Postal code
177948954
Phone
+98 51 3180 1191
Email
karimig@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Karimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil abad Blvd- Pharmacy school
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
0098513801191
Email
karimig@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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