Evaluation of the effectiveness of Iranian Borage Aerial Part infusion on the management of Covid-19 mild to moderate symptoms
Design
This clinical trial has a control group, and with parallel groups, double-blinded, randomized, phase 0, and is performed on 60 patients. The randomization method will be blocked randomization (Quaternary random blocks) using Random Allocation Software
Settings and conduct
This research will be conducted at Ali Asghar hospital in Shiraz, Iran. Sixty patients will be randomly located in one of two groups of the intervention or control groups. Patients in the intervention group will take the Iranian Borage Aerial Part infusion TID for 5 days in addition to the routine treatment for COVID-19. Patients in the control group will receive routine treatment and placebo. Routine blood tests and the need for intubation will be assessed. This is a double-blind trial and only the evaluator will know the results
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with COVID-19 confirmed by RT-PCR and Ground glass view on CT scan; Patients with COVID-19 symptoms who have been exposed to suspected people in the last 14 days; Having a conscious consent form signed to participate in the study; Not participating in similar studies at the same time
Exclusion criteria: People with a history of allergy to herbal medicines; Having liver, kidney, cardiovascular and endocrine diseases; Permanent use of psychiatric drugs; Pregnant and breastfeeding women; People who can't swallow
Intervention groups
Intervention groups will be two ones. Patients in the intervention group will receive Iranian Borage Aerial Part infusion in addition to the routine treatment, but in the control group, they will receive placebo in addition to the routine treatment.
Evaluation of the effectiveness of Iranian Borage Aerial Part infusion on the management of Covid-19 mild to moderate symptoms: a clinical trial
Public title
Effect of Iranian Borage on the management of Covid-19 symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 confirmed by RT-PCR and Ground glass view on CT scan
Patients with COVID-19 symptoms (such as fever, muscle pain, chest discomfort, cough, reduced CBC and platelets, increased CRP and ESR) who have been exposed to suspected people in the last 14 days
Having a conscious consent form signed to participate in the study
Not participating in similar studies at the same time
Exclusion criteria:
People with a history of allergy to herbal medicines
Having liver, kidney and cardiovascular diseases
Permanent use of psychiatric drugs
Pregnant and breastfeeding women
People who can't swallow
Having endocrine diseases like diabetes
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be blocked randomization (Quaternary random blocks). Randomization units are individuals. Sixty patients are randomly assigned to one of the two intervention and control groups using Random Allocation Software. This study is a double-blind method and patients in the intervention group will receive the intervention drug in addition to the routine treatment, but in the control group, they will receive the placebo in addition to the routine treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be a double-blind trial and only the evaluator knows the results and the code of the intervention or control group. The containers of the drug and placebo are quite similar in appearance. The intervention and control groups will be separated by receiving a code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
IR.SUMS.REC.1399.015
Health conditions studied
1
Description of health condition studied
corona virus (covid-19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Fever
Timepoint
At the beginning and end of the study
Method of measurement
Digital thermometer
2
Description
Respiratory status
Timepoint
At the beginning and end of the study
Method of measurement
Observation
3
Description
White blood cell count
Timepoint
At the beginning and end of the study
Method of measurement
Blood sample test
4
Description
Platelet blood count
Timepoint
At the beginning and end of the study
Method of measurement
Blood sample test
5
Description
Erythrocyte Sedimentation Rate
Timepoint
At the beginning and end of the study
Method of measurement
Blood sample test
6
Description
C-reactive protein
Timepoint
At the beginning and end of the study
Method of measurement
Blood sample test
7
Description
Vital capacity
Timepoint
At the beginning and end of the study
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive Iranian Borage Aerial Part infusion (1 g/100 cc water) TID for 5 days in addition to the routine treatment.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will receive the placebo (100 cc boiled water) TID for 5 days in addition to the routine treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali asghar hospital
Full name of responsible person
Mohammad Mehdi Zarshenas
Street address
Meshkinfam street
City
Shiraz
Province
Fars
Postal code
7143918796
Phone
+98 71 3228 8602
Fax
+98 71 3228 8907
Email
aliasghar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaeian zadeh
Street address
Central building of Shiraz university of medical sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad mehdi Zarshenas
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy, Karafrin Street
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
zarm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad mehdi Zarshenas
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy, Karafrin Street
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
zarm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahragard
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz school of pharmacy, Karafrin Street
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
a.sahragard646@gmail.com
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
Undecided - It is not yet known if there will be 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