Comparison of the Effectiveness of Standard Treatment with Standard Treatment plus licorice extract in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients
Comparison of the efficacy of standard treatment with standard treatment plus licorice extract on pulmonary symptoms and mortality rate in patients with COVID-19
Design
A randomized double-blind controlled clinical trial in 374 patients with COVID-19
Settings and conduct
The study is conducting in four University hospitals in Tehran. The study population is 374 patients with COVID-19. After giving sufficient explanations and obtaining written informed consent from the patient or first-degree relatives (in patients with low consciousness level or dementia), these patients are divided into two groups using permuted random blocks by random number table. The first or control group will receive only COVID-19 standard treatment based on the Ministry of Health's recommended protocol. The second group or trial group receive a herbal formulation of licorice in the form of 240 cc syrup at a dose of 10 cc 3 times daily for a maximum of 8 days, in addition to standard treatment.
Participants/Inclusion and exclusion criteria
Admitted patients with COVID-19
Diagnosis of COVID-19 by lung CT or PCR
Intervention groups
Group A are patients receiving standard COVID-19 treatment based on the Ministry of Health's protocol. Group B are patients who receive, in addition to standard treatment, a licorice-based herbal formulation in a 240 cc syrup, at a dose of 10 cc three times daily for a maximum of eight days.
Main outcome variables
Patient discharge; increase or decrease of the respiratory rate per minute as 25% initial; increase or decrease of O2 Saturation more than 10% upon arrival; the occurrence of heart, kidney, and pulmonary complications; Death
General information
Reason for update
Acronym
LCT-19
IRCT registration information
IRCT registration number:IRCT20160316027081N1
Registration date:2020-03-31, 1399/01/12
Registration timing:registered_while_recruiting
Last update:2020-03-31, 1399/01/12
Update count:2
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Saeed Soleiman-Meigooni
Name of organization / entity
AJA university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4414 4939
Email address
s.s.meigooni@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-23, 1399/01/04
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Standard Treatment with Standard Treatment plus licorice extract in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients
Public title
Effect of Licorice in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admitted patients with COVID-19 in the four hospitals of AJA medical University in Tehran
COVID-19 diagnosed by lung CT or naso-pharyngeal PCR
Exclusion criteria:
Severe hypersensitivity to the Licorice
DKA or NKHC
Pregnancy
Decompensated Cirrhosis
Non viral sepsis
Active GIB
Acute trauma or Surgical problem
Unstable angina or Acute MI
Chronic renal failure with Uremic symptoms
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
374
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permuted block randomization will be used for randomization. For this purpose six blocks consisting of AABB, ABAB, ABBA, BBAA, BABA, and BAAB are designated and then for each of four patients, one of these blocks will be assigned using the random digit table. In fact, according to the order specified in each block, two patients will receive protocol A (standard treatment of COVID) and two patients will receive protocol B (standard treatment of COVID plus licorice extract).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who have completed the informed consent form are not aware of their treatment protocol. Their physicians neither know which group is assigned to the patient at the beginning of the admission.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Shahre Ziba, Javanmardan Blvd, East Farsad St, Sarv Av, 1th Niloufar Alley, No 29
City
Tehran
Province
Tehran
Postal code
1487784637
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.AJAUMS.REC.1398.267
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J12.89
ICD-10 code description
Other viral pneumonia
2
Description of health condition studied
Acute bronchitis
ICD-10 code
J20.8
ICD-10 code description
Acute bronchitis due to other specified organisms
3
Description of health condition studied
Acute respiratory distress syndrome (ARDS)
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
Primary outcomes
1
Description
Patient discharge
Timepoint
Daily
Method of measurement
Yes or no
2
Description
Increase or decrease of respiratory rates more than 25% of primary respiratory rate
Timepoint
Daily
Method of measurement
Respiratory rate in minute
3
Description
Myocardial Infarction or unstable angina
Timepoint
Daily
Method of measurement
Yes or no
4
Description
Rising of creatinine more than 25% primary creatinine
Timepoint
Daily
Method of measurement
milligram in deciliter
5
Description
Patient death
Timepoint
Daily
Method of measurement
Yes or no
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients with COVID-19, in addition to standard treatment introduced by the Ministry of Health, the second drug is also prescribed. It is a licorice-based herbal extract that contains licorice, Rheum palmatum, Rosa damascene, Crocus sativus, and Ziziphus jujube. In order to prepare this extract, simple substances of these herbal are first prepared from the pharmaceutical market and after identification in the herbarium of the Faculty of Pharmacy of Tehran University of Medical Sciences, a herbarium code is assigned to each one. Then, a herbal syrup is extracted from these herbs by the maceration method. The syrup is standardized based on glycerol content, the total phenolic, and flavonoids compounds by HPLC method. Microbial controls are performed on the syrup. The syrup is packaged in 240 cc dark pets and given to the patient and at a dose of 10 cc every 8 hours for up to 8 days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive only standard treatment provided by the Ministry of Health for COVID-9.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat
Full name of responsible person
Dr.Mohammad Aminianfar
Street address
Basij Blvd, Hejrat St
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.com
2
Recruitment center
Name of recruitment center
Khanevadeh
Full name of responsible person
Dr.Saeed Soleiman-Meigooni
Street address
Shari'ati Blvd, Kaaj St
City
Tehran
Province
Tehran
Postal code
1613917149
Phone
+98 21 7760 0500
Email
dr.saeed.meigooni@gmail.com
3
Recruitment center
Name of recruitment center
Imam Reza
Full name of responsible person
Dr. Ali Asgari
Street address
Fatemi St, E'temad Zadeh Av
City
Tehran
Province
Tehran
Postal code
1411718701
Phone
+98 21 8609 6350
Email
aliasgari222@gmail.com
4
Recruitment center
Name of recruitment center
Golestan
Full name of responsible person
Dr. Amir Ezzati
Street address
Sayyad Highway
City
Tehran
Province
Tehran
Postal code
1668649551
Phone
+98 21 2254 9002
Email
dr_meigooni@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Hamidi Farahani
Street address
Fatemi St, E'temad Zadeh Av
City
Tehran
Province
Tehran
Postal code
1411718701
Phone
+98 21 8609 6350
Email
admin@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Dr. Saeed Soleiman Meigooni
Position
Deputy of Research
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No 29, 1th Niloufar, Sarv Av, east Farsad, St, Javanmardan Bolv, Shahr-e-Ziba
City
Tehran
Province
Tehran
Postal code
1487784637
Phone
+98 21 4414 4939
Fax
+98 21 5579 2554
Email
dr.saeed.meigooni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Saeed Soleiman-Meigooni
Position
Deputy of research
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No 29, 1th Niloufar Alley, Sarv Av, east Farsad St, Javanmardan Blvd, Shahr e Ziba
City
Tehran
Province
Tehran
Postal code
1487784637
Phone
+98 21 4414 4939
Fax
+98 21 5579 2554
Email
Dr.saeed.meigooni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr.Saeed Soleiman Meigooni
Position
Deputy of Research
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No 29, 1th Niloufar Alley, Sarv Av, east Farsad St, Javanmardan Blvd, Shahr e Ziba
City
Tehran
Province
Tehran
Postal code
1487784637
Phone
+98 21 4414 4939
Fax
+98 21 5579 2554
Email
dr.saeed.meigooni@gmail.com
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
Questionnaire
When the data will become available and for how long
After one year
To whom data/document is available
Deputy of research, Ministry of health
Under which criteria data/document could be used
After formal request
From where data/document is obtainable
AJA University of medical sciences, deputy of research
What processes are involved for a request to access data/document
From:
Ministry of Health, Deputy of Research
To:
AJA University of Medical Sciences
Comments
We are not permitted to publish the information of the military patients unprepared.