Determining the effect of Persian medicine products on O2 saturation in patients with or suspected of COVID-19
Determining the Effect of Persian medicine products on Respiratory Rate in Patients With or Suspected of COVID-19
The effect of Persian medicine products on CRP levels of patients with or suspected of COVID-19
The effect of Persian medicine products on lymphocyte levels in patients with or suspected of COVID-19
Determining the effect of Persian medicine products on WBC levels in patients with or suspected of COVID-19
Design
A randomized clinical trial with two group: control and intervention
Settings and conduct
The study will be conducted at Imam Reza Hospital. Patients will be randomly divided into intervention and control groups. Given the open-label study, Blinding will not happen.
Participants/Inclusion and exclusion criteria
Patients over 18 years old hospitalized with or suspected of COVID-19: Liver, kidney and heart failure, Immunodeficiency, Pregnancy and breast feeding, Hypertension, Alcohol or drug addiction, A history of allergies to medicinal herbs, Patients with transplanted organs, Cor Pulmonel Patients, History of deep vein thrombosis
Intervention groups
Intervention group: standard treatment, Persian medicine capsule, Persian medicine syrup
Control group: standard treatment
Main outcome variables
Oxygen saturation: Respiratory Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140617018126N2
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Mostafa Araj-Khodaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9528
Email address
araj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Persian Medicine Products on the Clinical and Laboratory Symptoms of Patients With or Suspected of Covid-19
Public title
Persian Medicine Products in Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old patients hospitalized, with or suspected of COVID-19
Exclusion criteria:
Having liver, kidney and heart failure
History of immunodeficiency
Breastfeeding and pregnancy
Hypertension
Alcohol or drug addiction
A history of allergies to medicinal herbs
Patients with transplanted organs
Cor Pulmonale Patients
History of deep vein thrombosis
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment).The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Iranian medicine products and control group (Assignment). Then based on blocks and allocation sequences medication will be given to patients. This is an open-label study and blinding will not happen.
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 Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.TBZMED.REC.1398.1318
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
RA01.0
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Oxygen saturation
Timepoint
Clinical examination and Pulse Oximetry before starting medication and regularly during treatment
Method of measurement
Pulse Oximeter
2
Description
Respiratory Rate
Timepoint
Clinical examination before starting medication and regularly during treatment
Method of measurement
respiratory Count
Secondary outcomes
1
Description
C-reactive protein
Timepoint
Intravenous blood testing before starting medication and during treatment
Method of measurement
Intravenous blood test
2
Description
Lymphocytes
Timepoint
Intravenous blood testing before starting medication and during treatment
Method of measurement
Intravenous blood test
3
Description
White Blood Cells
Timepoint
Intravenous blood testing before starting medication and during treatment
Method of measurement
Intravenous blood test
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the standard treatment, medicinal herbal products will be prescribed. The drug will be given in two combination forms. One in the form of a syrup containing the following medicinal herbs: Zattaria multiflora, Punicagranatum, Marticaria chamomilla, Zizyphus sativa and Mentha spp, and the other in the form of a capsule containing the following medicinal herbs: Rheum officinale, nigella Sativa andnepeta bracteata . In addition to the usual treatment, the intervention group, will receive a capsule every 8 hours and 10 cc of of Iranian medicine syrup every 8 hours for one week. The capsule will be taken at least half an hour after taking the syrup.
Category
Treatment - Drugs
2
Description
Control group: Get standard treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Hojjat Pourfathi Nematabad
Street address
Imam Reza Hospital, Opposite the Central Organization of the Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 5921
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hojjat Pourfathi Nematabad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4672
Email
hojjatpourfathi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hojjat Pourfathi Nematabad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4672
Email
hojjatpourfathi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hojjat Pourfathi Nematabad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4672
Email
hojjatpourfathi@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