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Comparison of the Effectiveness of Standard Treatment with Standard Treatment plus licorice extract as adjunctive treatment in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients

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History
# Registration date Revision Id
3 2022-03-03, 1400/12/12 218887
2 2022-02-15, 1400/11/26 218818
1 2020-03-31, 1399/01/12 127489
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  • Protocol summary

    Comparison of the efficacy of standard treatment with standard treatment plus licorice extract on pulmonary symptoms and mortality rate in patients with COVID-19
    Comparison of the efficacy of standard treatment with standard treatment plus licorice extract as adjunctive treatment on pulmonary symptoms and mortality rate in patients with COVID-19
    مقایسه تاثیر درمان استاندارد با درمان استاندارد توام با عصاره شیرین بیان بر روی علائم ریوی و میزان مرگ و میر بیماران بستری مبتلا به کووید 19
    مقایسه تاثیر درمان استاندارد با درمان استاندارد توام با عصاره شیرین بیان به عنوان درمان کمکی بر روی علائم ریوی و میزان مرگ و میر بیماران بستری مبتلا به کووید 19
    A randomized double-blind controlled clinical trial in 374 patients with COVID-19
    A randomized phase 2 controlled clinical trial on 190 patients with COVID-19
    کارآزمایی بالینی دارای گروه کنترل دو سویه کور تصادفی شده فاز 3 یر روی 374 بیمار مبتلا به کووید 19
    کارآزمایی بالینی دارای گروه کنترل تصادفی شده فاز ۲ بر روی ۱۹۰ بیمار مبتلا به کووید 19
    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.
    The study is conducted in four University hospitals in Tehran. The study population is 190 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 based on a permuted four-block randomization and a 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.
    این مطالعه در چهار بیمارستان آموزشی در شهر تهران انجام می شود. جمعیت مورد مطالعه 374 بیمار مبتلا به کووید 19 است. بعد از دادن توضیحات کافی و اخذ رضایت آگاهانه کتبی از بیمار و یا بستگان درجه اول (در بیماران با هوشیاری پایین و یا دمانس)، این بیماران به روش تصادفی بلوکی با استفاده از جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول یا گروه کنترل فقط درمان استاندارد COVID-19 بر پایه پروتکل پیشنهادی وزارت بهداشت دریافت می کنند. گروه دوم یا آزمودنی علاوه بر درمان استاندارد، یک فرمولاسیون گیاهی بر پایه شیرین بیان بصورت یک شربت 240 سی سی به میزان 10 سی سی 3 بار در روز به مدت حداکثر 8 روز دریافت می کنند.
    این مطالعه در چهار بیمارستان آموزشی در شهر تهران انجام می شود. جمعیت مورد مطالعه 190 بیمار مبتلا به کووید 19 است. بعد از دادن توضیحات کافی و اخذ رضایت آگاهانه کتبی از بیمار و یا بستگان درجه اول (در بیماران با هوشیاری پایین و یا دمانس)، این بیماران به روش تصادفی با استفاده از بلوک های ۴ تایی و جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول یا گروه کنترل فقط درمان استاندارد COVID-19 بر پایه پروتکل پیشنهادی وزارت بهداشت دریافت می کنند. گروه دوم یا آزمودنی علاوه بر درمان استاندارد، یک فرمولاسیون گیاهی بر پایه شیرین بیان بصورت یک شربت 240 سی سی به میزان 10 سی سی 3 بار در روز به مدت حداکثر 8 روز دریافت می کنند.
    Admitted patients with COVID-19; Diagnosis of COVID-19 by lung CT or PCR
    admitted patients with COVID-19 Diagnosis of COVID-19 by lung CT or PCR
    بیمار بستری مبتلا به کووید 19 تشخیص COVID-19 بر اساس CT ریه یا PCR
    بیمار مبتلا به کووید 19 بستری در بخش کووید تشخیص COVID-19 بر اساس CT ریه یا PCR
    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
    The duration of hospitalization in survivors.
    ترخیص بیمار; کاهش یا افزایش تعداد تنفس در دقیقه به میزان 25% اولیه; کاهش یا افزایش اکسیژناسیون خون به میزان بیش از 10% بدو ورود; بروز عوارض قلبی، کلیوی، ریوی; فوت بیمار
    مدت زمان بستری در افراد بهبود یافته

  • General information

    LCT-19
    empty
    18
    empty
    Year
    Yes
    No
    Double blinded
    Not blinded
    1
    1
    1
    1
    1
    1
    Treatment
    Supportive
    3
    2
    374
    190
    empty
    185
    empty
    2020-04-01, 1399/01/13
    empty
    2020-06-01, 1399/03/12
    empty
    2020-07-01, 1399/04/11
    empty
    We requested to update the trial based on the national scientific committee on Covid-19
    empty
    اصلاحات با توجه به نظر داوران در کمیته ملی کورونا درخواست گردید
    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 Effectiveness of Standard Treatment with Standard Treatment plus licorice extract as adjunctive treatment in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients
    مقایسه اثربخشی درمان استاندارد با درمان استاندارد توام با عصاره شیرین بیان در بهبود علائم تنفسی و میزان بقاء بیماران مبتلا به کووید 19
    مقایسه اثربخشی درمان استاندارد با درمان استاندارد توام با عصاره شیرین بیان به عنوان درمان کمکی در بهبود علائم تنفسی و میزان بقاء بیماران مبتلا به کووید 19
    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).
    In this study, we use a permuted four-block randomization method. 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).
    در این مطالعه به منظور تصادفی‌سازی، از روش تصادفی‌سازی بلوکی استفاده خواهد شد. بدین منظور ۶ بلوک شامل AABB، ABAB، ABBA، BBAA، BABA و BAAB تعیین شده و سپس به ترتیب برای هر ۴ بیمار، یکی از این ۶ بلوک با استفاده از جدول اعداد تصادفی استفاده خواهد شد. در واقع بر اساس ترتیب مشخص شده در هر بلوک، دو بیمار پروتکل A (درمان استاندارد کووید) و دو بیمار پروتکل B (درمان استاندارد کووید توام با محلول دارویی شیرین‌بیان) را دریافت خواهند نمود.
    در این مطالعه ما از روش تصادفی‌سازی بلوکی ۴ تایی استفاده خواهیم کرد. بدین منظور ۶ بلوک شامل AABB، ABAB، ABBA، BBAA، BABA و BAAB تعیین شده و سپس به ترتیب برای هر ۴ بیمار، یکی از این ۶ بلوک با استفاده از جدول اعداد تصادفی استفاده خواهد شد. در واقع بر اساس ترتیب مشخص شده در هر بلوک، دو بیمار پروتکل A (درمان استاندارد کووید) و دو بیمار پروتکل B (درمان استاندارد کووید توام با محلول دارویی شیرین‌بیان) را دریافت خواهند نمود.
    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.
    بیمارانی که فرم رضایت آگاهانه را جهت شرکت در پژوهش تکمیل کرده اند، از پروتکل درمانی خود اطلاع ندارند. پزشکان معالج بیماران در ابتدای بستری نمی دانند که بیمار در کدام گروه درمانی قرار دارد.

  • Primary outcomes

    #1
    Patient discharge
    Admission time
    ترخیص بیمار
    مدت زمان بستری
    #2
    Increase or decrease of respiratory rates more than 25% of primary respiratory rate
    empty
    افزایش یا کاهش میزان تنفس در دقیقه به میزان بیش از 25 درصد اولیه
    empty
    Daily
    empty
    روزانه
    empty
    Respiratory rate in minute
    empty
    تعداد تنفس در دقیقه
    empty
    #3
    Myocardial Infarction or unstable angina
    empty
    سکته قلبی یا آنژین صدری ناپایدار
    empty
    Daily
    empty
    روزانه
    empty
    Yes or no
    empty
    بلی یا خیر
    empty
    #4
    Rising of creatinine more than 25% primary creatinine
    empty
    افزایش کراتینین بیش از 25% اولیه
    empty
    Daily
    empty
    روزانه
    empty
    milligram in deciliter
    empty
    میلیگرم در دسی لیتر
    empty
    #5
    Patient death
    empty
    فوت بیمار
    empty
    Daily
    empty
    روزانه
    empty
    Yes or no
    empty
    بلی یا خیر
    empty

  • Secondary outcomes

    #1
    On admission, On the day 4
    On admission, On discharge
    بدو مراجعه، روز چهارم
    بدو مراجعه و زمان ترخیص
    #2
    empty
    differences in lymphocyte count
    empty
    اختلاف شمارش لنفوسیتی
    empty
    on admission, on discharge
    empty
    بدو مراجعه و زمان ترخیص
    empty
    with the cell counter device
    empty
    با دستگاه سل کانتر
    #3
    empty
    the death number
    empty
    تعداد موارد فوت
    empty
    at the end of admission
    empty
    در انتهای بستری
    empty
    base on the patient registries
    empty
    از روی پرونده

  • Intervention groups

    #1
    Placebo
    Treatment - Drugs

Protocol summary

Study aim
Comparison of the efficacy of standard treatment with standard treatment plus licorice extract as adjunctive treatment on pulmonary symptoms and mortality rate in patients with COVID-19
Design
A randomized phase 2 controlled clinical trial on 190 patients with COVID-19
Settings and conduct
The study is conducted in four University hospitals in Tehran. The study population is 190 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 based on a permuted four-block randomization and a 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
The duration of hospitalization in survivors.

General information

Reason for update
We requested to update the trial based on the national scientific committee on Covid-19
Acronym
IRCT registration information
IRCT registration number: IRCT20160316027081N1
Registration date: 2020-03-31, 1399/01/12
Registration timing: prospective

Last update: 2022-03-03, 1400/12/12
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
2020-04-01, 1399/01/13
Actual recruitment end date
2020-06-01, 1399/03/12
Trial completion date
2020-07-01, 1399/04/11
Scientific title
Comparison of the Effectiveness of Standard Treatment with Standard Treatment plus licorice extract as adjunctive treatment in Improving Respiratory Symptoms and Survival Rate in COVID-19 Patients
Public title
Effect of Licorice in COVID-19
Purpose
Supportive
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
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 190
Actual sample size reached: 185
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use a permuted four-block randomization method. 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)
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 AJA University of Medical Sciences
Street address
No 29, 1th Niloufar Ave, Sarv St, East Farsad St, avanmardan Blvd, Shahre Ziba
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
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Admission time
Timepoint
Daily
Method of measurement
Patients' profile (Yes or no)

Secondary outcomes

1

Description
C-reactive protein
Timepoint
On admission, On discharge
Method of measurement
Laboratory test

2

Description
differences in lymphocyte count
Timepoint
on admission, on discharge
Method of measurement
with the cell counter device

3

Description
the death number
Timepoint
at the end of admission
Method of measurement
base on the patient registries

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
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Be'sat hospital
Full name of responsible person
Dr.Mohammad Aminianfar
Street address
Hejrat St, Basij Blvd, Afsarieh
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.com

2

Recruitment center
Name of recruitment center
Khanevadeh hospital
Full name of responsible person
Dr.Saeed Soleiman-Meigooni
Street address
Kaaj St, Shari'ati Blvd
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 hospital
Full name of responsible person
Dr. Ali Asgari
Street address
E'temad Zadeh Av, Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718701
Phone
+98 21 8609 6350
Email
aliasgari222@gmail.com

4

Recruitment center
Name of recruitment center
Golestan hospital
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
E'temad Zadeh Av, Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718701
Phone
+98 21 8609 6350
Email
admin@ajaums.ac.ir
Web page address
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.
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