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Clinical trials of a syrup from three medicinal plants with effective index glycyrrhizin index in reducing inflammation, cough, and duration of hospitalization caused by Covid-19

Protocol summary

Study aim
study on the effects of Hero Syrup on the outcome and death of COVID-19 infection of human
Design
Patients would be randomly divided into 2 arm parallel groups by Stratified allocation method and treated in a triple-blind clinical trial. The patients would be subgrouped into 8 laid depending on the severity of infection, sex, and age (over 45 years old and below). For each subgroup, there would be random permuted blocks. There would be 41 patients in each group. After the first phase of the trial, if the result were satisfactory, the trial would proceed into the 2nd phase and the drug would be tested on 100 patients.
Settings and conduct
This trial would be a triple-blinded clinical examination of the Hero Syrup on COVID-19 patients of Yasudj City of Iran. The Syrup would be prepared in Khrramabd Medical and Pharmacology Schools labeled and will be sent for a clinical trial in the Imam Sadjad Hospital of Yasudj city. The Doctors, patients, and data analyzers all would be blinded for the drug or placebo in both sites.
Participants/Inclusion and exclusion criteria
patients aged between18 to 65 who have proven to be infected with SARS Cov2 and have the ability to consume the drug and answer the questions in the interview are eligible for participation in the study. Patients who are hospitalized in the ICU ward, pregnant or has hypersensitivity to the drug will not accepted to this study.
Intervention groups
patients would be randomly divided into 2 groups (Stratifi8ed random allocation) The test groups also would be divided into 8 layers depending on the severity of infection, sex, and age groups. The control group also would be equally divided.
Main outcome variables
The triple-blinded clinical trial would assess the in the following rates : death, need for hospitalization, need for ICU room, need for ventilation of the patient, cough, and time to recovery from the COVID-19 infection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220830055834N1
Registration date: 2023-01-25, 1401/11/05
Registration timing: registered_while_recruiting

Last update: 2023-01-25, 1401/11/05
Update count: 0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Gholam Reza Talei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3330 0661
Email address
taleireza@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-03, 1401/09/12
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of a syrup from three medicinal plants with effective index glycyrrhizin index in reducing inflammation, cough, and duration of hospitalization caused by Covid-19
Public title
Clinical trial for a herbal syrup (named Hero) in reduction of COVID 19 respiratory infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years old Proven infection with COVID - 19 Ability (mental and physical ) to use the drug syrup Lack of hypersensitivity to the drug and similar compounds. Ability to respond to contact and interview about the effectiveness of the drug. patient must have not be hospitalized in the ICU ward.
Exclusion criteria:
Negative criteria for COVID-19 infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drug or placebo would be prepared in Khorramabad City and after labelling with a code number and A or B group would be recorded by Secretary of Research of the Lorestan University of(LUMS) and the code would be stored in his safe in his office. The bottles of drugs and placebo are all would be similar in all aspects except number of labels. The bottles then would be send to Yasuj City for Clinical trials. Assignment of recipient of drugs or placebo would be based on Stratified Random Allocation method. This would be based on severity of infection(mild or moderate) , age and sex(8 groups ). In each group there would be random permuted block method for allocation of participants. At the end the data would be analyzed in 2 groups (A and B) by the Biostatistician and the decoder would open the labels for conclusion of the results.
Placebo
Used
Assignment
Parallel
Other design features
Two groups are different by the severity of infection

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Lorestan University of Medical Sciences
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6815144311
Approval date
2021-01-12, 1399/10/23
Ethics committee reference number
IR.LUMS.REC.1399.313

Health conditions studied

1

Description of health condition studied
Respiratory Infection of COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19: confirmed by laboratory testing

Primary outcomes

1

Description
pressure of Oxygen in the blood
Timepoint
At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day up to the end of the trial
Method of measurement
Oxymeter for blood oxygen

2

Description
shortness of breath
Timepoint
At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day up to the end of the trial
Method of measurement
observation for shortage of breath

3

Description
fever
Timepoint
At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day up to the end of the trial
Method of measurement
Thermometer for fever

4

Description
cough
Timepoint
At the admission time and every hour for the first 12 hours, depending on the severity of symptoms every 1 hour. then twice a day up to the end of the trial
Method of measurement
observation of cough

Secondary outcomes

1

Description
The death rate would be compared in 2 groups of test and control. In the test group, they received Hero Syrup and routine treatment, and in the control group, they received only routine treatment.
Timepoint
At the end of 14 days of infection period
Method of measurement
Counting the death of patients in 2 groups according to the hospital report and comparing it.

2

Description
Counting the patients who were hospitalized in the ICU and the duration of their hospitalization in that ward.
Timepoint
from the beginning of the symptoms for 14 days, if the patient needed ICU, the duration of hospitalization in the ward would be recorded according to the hospital record.
Method of measurement
Counting the days of hospitalization in the ICU ward according to the hospital record.

3

Description
patients who needed Ventilators during the 14 days of clinical COVID-19 infection would be followed, counted, and compared.
Timepoint
At the end of 14 days of COVID-19 infection, those patients who needed Ventilators would be followed counted, and compared.
Method of measurement
Patients who needed the use of Ventilation would be counted and compared in these 2 groups

4

Description
Day(s) of hospitalization in ICU ward, if necessary, would bge compared in two groups
Timepoint
from the beginning of the symptoms for 14 days, if the patient needed ICU, the duration of hospitalization in the ward would be recorded according to the hospital record and compared in the 2 groups
Method of measurement
Counting the days of hospitalization in the ICU ward according to the hospital record and would be compared

5

Description
patients who needed a Ventilator during the 14 days of clinical COVID 19 infection would be followed and days of this requirement would be compared in two groups.
Timepoint
At the end of 14 days of COVID-19 infection
Method of measurement
At the end of 14 days of COVID-19 infection, days of used Ventilators by patients would be counted and compared.

Intervention groups

1

Description
Control group: The routine treatment would be given to this group as well as Placebo which would look and taste like the Hero Syrup.
Category
Treatment - Drugs

2

Description
Intervention group: There would be a routine treatment for this group as well as the Hero Syrup which would be given according to the protocol for 7 days (3 times a day with 350 milligrams/mili liter)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sadjad Hospital of Yasudj City
Full name of responsible person
Dr. Gholam Abbas Sabz
Street address
Pezeshk Street
City
Yasudj City
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Fax
+98 74 3322 0168
Email
emamsajad@yums.ac.ir
Web page address
https://research.yums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Professor Bahram Rasulian
Street address
Lorestan University of Medical Sciences, Kamalvand, Pardis, Khorramabad, Lorestan, Iran.
City
Khorramabad
Province
Lorestan
Postal code
6815144311
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
researchlums@lums.ac.ir
Web page address
http://research.lums.ac.ir/
Grant name
1805003000 Research for practical use
Grant code / Reference number
1805003000شماره برنامه
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
60
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

2

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Abbas Sabz
Street address
Pezeshk Street
City
yasudj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0165
Fax
+98 74 3322 0168
Email
emamsajad@yums.ac.ir
Web page address
https://research.yums.ac.ir/
Grant name
Resarch for application use number 124010
Grant code / Reference number
پژوهش های علمی کاربردی به شماره دستگاه اجرایی 124410
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
40
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Gholam Reza Talei
Position
َAssociate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Kamalvand, Pardis Lorestan University of Medical Sciences,
City
Khorramabad
Province
Lorestan
Postal code
6815144311
Phone
+63 3120175
Fax
+98 66 3312 0175
Email
taleireza@gmail.com
Web page address
http://med.lums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Doctor. Gholam Reza Talei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Kamalvand, Pardis , Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6815144311
Phone
009866133120133
Fax
Email
taleireza@yahoo.com
Web page address
http://en.lums.ac.ir/index.php?module=fdk&func=loadmodule&system=fdk&sismodule=management/content_view.php&sisOp=view&ctp_id=58&cnt_id=78093&id=189

Person responsible for updating data

Contact
Name of organization / entity
Ghohar Shafa Medical device manfactory
Full name of responsible person
Somaieh Sabzali
Position
Quality Control manager
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Anoshirvan avenio, Shora sterit
City
Khorramabad
Province
Lorestan
Postal code
6816694774
Phone
+98 66 3331 3210
Email
Sabzali.somaieh@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
Confidentiality of patients
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not 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
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