Determining the effectiveness of the natural product Faramir containing Salvia officinalis extract as antiviral and anti-inflammatory treatment in COVID-19 patients
Design
Two arm parallel group randomized double-blind controlled trial
Settings and conduct
Patients are recruitedn in Loghman Hospital and assigned in two parallel groups randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Covid-19 infection confirmed by positive PCR-viral load test
Some or all of the symptoms include fever, fatigue, muscle aches (headache), headache, cough, chest tightness, and shortness of breath
Need to be hospitalized
Exclusion criteria:
Malignant tumors and other acute systemic diseases
Co-infection with HIV and tuberculosis
History of asthma, asthma-like attacks and respiratory problems
Life-threatening comorbidity
Use of any other herbal substance
Homofusion and plasmapheresis
Drug allergy
Need for hospitalization in the intensive care unit (ICU)
Pregnancy
Lactation
Intervention groups
Intervention group: Patients who receive natural product Faramir along with standard treatments.
Control group: Patients who receive only standard treatments
Main outcome variables
Mortality rate, discharge duration and virus clearance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033086N7
Registration date:2020-11-12, 1399/08/22
Registration timing:prospective
Last update:2020-11-12, 1399/08/22
Update count:0
Registration date
2020-11-12, 1399/08/22
Registrant information
Name
Saeed Karima
Name of organization / entity
Shahid Beheshti University of Medical Sciences (SBMU)
Country
Iran (Islamic Republic of)
Phone
+98 21 9666 1028
Email address
karima@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation of the impact of Faramir containing Salvia officinalis leaf extract on the level of serum IL-6 in patients with COVID-19
Public title
An Investigation of the impact of Faramir on the clinical symptoms in patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-19 infection confirmed by positive PCR-viral load test
Some or all of the symptoms include fever, fatigue, muscle aches (headache), headache, cough, chest tightness, and shortness of breath
Need to be hospitalized
Exclusion criteria:
Malignant tumors and other acute systemic diseases
Co-infection with HIV and tuberculosis
History of asthma, asthma-like attacks and respiratory problems
Life-threatening comorbidity
Use of any other herbal substance
Homofusion and plasmapheresis
Drug allergy
Need for hospitalization in the intensive care unit (ICU)
Pregnancy
Lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the patient-assigned code and the order of recruitment is generated by an epidemiologist using Stata v.15. Given the block size of 4, there are 6 possible ways to equally assign participants to each treatment group. Therefore recruitment of participants to each treatment category is randomized and unpredictable. Following this randomization, an equal number of participants is randomly assigned to each treatment group.
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 Shahid Beheshti University of Medical Sciences, School of Medicine
At the beginning of the study and 8 days after the study commencement
Method of measurement
Western green method
Intervention groups
1
Description
Intervention group: Patients who receive natural product Faramir containing Salvia officinalis extract (750 mg oral caplet, 6 times a day, every 4 hours and for 8 days) along with standard treatments.The active ingredient of the medicinal species of ُSalvia officinali is prepared from the leaves of the medicinal species of the plant by Meem Pharmaceutical Factory and will be stored in closed containers in conditions away from light and moisture.
Category
Treatment - Drugs
2
Description
Control group: Patients who receive only standard treatments
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hospital
Full name of responsible person
Minoosh Shabani
Street address
Makhsoos st., Lashgar junction
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
minoosh.shabani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Karima
Street address
Velenjak, Kudakyar st.
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 2243 9974
Email
karima@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Behbalin
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoosh Shabani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Makhsoos st., Lashgar junction
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
minoosh.shabani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Behbalin
Full name of responsible person
Somayeh Mahmoodi Baram
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Niyayesh Highway, Shahid Beheshti University of Medical Sciences Incubator Center
City
تهران
Province
Tehran
Postal code
1996835113
Phone
+98 21 9666 1028
Email
info@behbalin.com
Person responsible for updating data
Contact
Name of organization / entity
Behbalin
Full name of responsible person
Somayeh Mahmoodi Baram
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Niyayesh Highway
City
تهران
Province
Tehran
Postal code
1996835113
Phone
+98 21 9666 1028
Email
info@behbalin.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
collected de-identified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
De-identified data will be available starting from April, 2025
To whom data/document is available
Academics employed at various research/university institutions and the industry.
Under which criteria data/document could be used
No specific condition are specified.
From where data/document is obtainable
Recruitment center
What processes are involved for a request to access data/document
1- The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes. 2- Following the receipt of request letter, the data would be provided in no more than two weeks.