Protocol summary

Study aim
Evaluation of the effect of herbal oral product (thyme syrup) in patients with COVID-19
Design
152 patients between the ages of 30 and 65 with a probable diagnosis of COVID-19 according to the national protocol, after applying the inclusion and exclusion criteria of the study and completing the conscious consent form with block randomization are placed in one of the intervention and control groups.
Settings and conduct
This study is a type of clinical trial that is not blind and patients who refer to Imam Khomeini Hospital in Sari are diagnosed with COVID-19 manifestation will entered. Then, 152 patients between the ages of 30 and 65 with a probable diagnosis of COVID-19 according to the national protocol, after applying the inclusion and exclusion criteria of the study and completing the conscious consent form with block randomization are placed in one of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Patients between 30 and 65 years with Probable diagnosis of COVID-19 based on national Iranian protocol
Intervention groups
Intervention group: Corona standard treatment + herbal syrup (Iranian medicine product made by the research team): 100 cc of the syrup is mixed with 100 cc of hot water and eaten 30 minutes after a meal (three times a day). Control group: Corona standard treatment according to the national protocol of the Ministry of Health of Iran.
Main outcome variables
Blood oxygen saturation, shortness of breath, length of hospital stay

General information

Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number: IRCT20131129015584N2
Registration date: 2020-05-08, 1399/02/19
Registration timing: registered_while_recruiting

Last update: 2020-05-08, 1399/02/19
Update count: 0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Assie Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
arezoo2003dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of herbal oral product (thyme syrup) in patients with COVID-19
Public title
The effect of herbal syrup on patients with corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Probable diagnosis of COVID-19 based on national Iranian protocol
Exclusion criteria:
Late 5 days from the onset of symptoms Existence of comorbidity Pregnancy and lactation history of Allergy Complicated with bacterial infection
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Randomized
Randomization description
Before intervention, each patient selects one of the 152 envelopes that contain the codes 0001 to 0152, then by having the selected code and using the output table of Block randomization statistical software, it is determined the patient in which group: intervention or controls.
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 Mazandaran University of Medical Sciences
Street address
Moallem squre, Sari, Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.MAZUMS.REC.1398.1456

Health conditions studied

1

Description of health condition studied
ARDS
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome

Primary outcomes

1

Description
Blood oxygen saturation level
Timepoint
0,1,2,3,5,7 days after intervention
Method of measurement
Pulse oximetry

Secondary outcomes

1

Description
degree of dyspnea
Timepoint
0,1,2,3,5,7 days after intervention
Method of measurement
Likert,s scale

2

Description
Duration of hospital stay
Timepoint
7days after intervention
Method of measurement
day

Intervention groups

1

Description
Intervention group: standard treatment of COVID-19 + herbal syrup (Iranian medicine product made by the research team): 100 cc of the syrup is mixed with 100 cc of hot water and eaten 30 minutes after a meal (three times a day).
Category
Treatment - Drugs

2

Description
Control group: standard treatment of COVID-19(Kaletra+ Azitromycine)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Assie Jokar
Street address
Imam Khomeini Hospital of Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Fax
+98 11 3336 3754
Email
publicrel@mazums.ac.ir
Web page address
https://imamhospital.mazums.ac.ir/page-NImamSariMain/fa/94/form/pId25046

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Moallem squre
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Web page address
https://pajooheshi.mazums.ac.ir/page-NPajooheshiMain/fa/2/form/pId47946
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
70
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
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4814878787
Phone
+98 11 3324 3117
Fax
Email
a-jokar@razi.tums.ac.ir
Web page address
https://scholar.google.com/citations?user=25VPUvwAAAAJ&hl=en

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4814878787
Phone
+98 11 3324 3117
Fax
Email
a.jokar@mazums.ac.ir
Web page address
https://scholar.google.com/citations?user=25VPUvwAAAAJ&hl=en

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4814878787
Phone
+98 11 3324 3117
Fax
Email
a.jokar@mazums.ac.ir
Web page address
https://scholar.google.com/citations?user=25VPUvwAAAAJ&hl=en

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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the main and secondary outcomes
When the data will become available and for how long
After the publication of the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
After the publication of the article
From where data/document is obtainable
The person responsible for scientific accountability
What processes are involved for a request to access data/document
Communication with the person responsible for scientific accountability
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