Effects of Viroherb capsule and Fenugreek syrup derived from traditional Persian medicine on clinical and paraclinical outcomes and survival of patients with mild to moderate COVID-19 hospitalized in medical centers of Tehran University of Medical Sciences
Evaluation of the effect of Viroherb and Fenugreek in clinical and paraclinical outcomes and survival rate of patients with mild to moderate form of COVID-19
Design
Multicenter, randomized by block randomization, controlled, paralled group, open label clinical trial, sample size: 110
Settings and conduct
This study will be conducted in three medical centers of Tehran University of Medical Sciences (Amiralam, Ziaeeian, and Baharlou hospitals). Patients fulfilled inclusion criteria will be divided randomly in two groups: intervention group and control group. The study is open label. Duration of study is 5 days and outcomes will be measured at the beginning of study and on day 6.
Participants/Inclusion and exclusion criteria
patients aged 18 years or more with mild to moderate form of COVID-19
Intervention groups
Intervention group: Received medications according national guideline plus Viroherb capsule (2 caps bid) and Fenugreek syrup (10 cc qid)
Control group: Received medications according national guideline
Main outcome variables
Clinical outcomes including fever, cough, dyspnea, myalgia; safety and adverse events of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200402046923N1
Registration date:2020-04-09, 1399/01/21
Registration timing:registered_while_recruiting
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Roja Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 0835
Email address
rojarahimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2020-05-06, 1399/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Viroherb capsule and Fenugreek syrup derived from traditional Persian medicine on clinical and paraclinical outcomes and survival of patients with mild to moderate COVID-19 hospitalized in medical centers of Tehran University of Medical Sciences
Public title
Effect of herbal capsule, Viroherb, and herbal syrup, Fenugreek in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to understand and the willingness to sign a written informed consent document
Aged 18 and more without sex restriction
patients with mild to moderate form of COVID-19 according to national guideline
not recieved any retroviral or immunostimulant medications in the past 3 months
Exclusion criteria:
pregnancy or lactation
patients in whom COVID-19 in not confirmed
Alcohol or drug addiction
patients with hypertension
patients with peptic ulcer
patients with diabetes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
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 intervention and control (Assignment). Then based on blocks and allocation sequences medication will be given to patients.
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 Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-04-02, 1399/01/14
Ethics committee reference number
IR.TUMS.VCR.REC.1399.099
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Body temperature
Timepoint
At the beginning of the study and on day 6
Method of measurement
thermometer
2
Description
Adverse events
Timepoint
whole duration of study
Method of measurement
type and number of adverse event
3
Description
cough
Timepoint
At the beginning of the study and on day 6
Method of measurement
clinical judgement of physician
4
Description
dyspnea
Timepoint
At the beginning of the study and on day 6
Method of measurement
clinical judgement of physician
5
Description
Myalgia
Timepoint
At the beginning of the study and on day 6
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Liver enzymes (ALT, AST)
Timepoint
At the beginning of study and day 6
Method of measurement
Laboratory refferal
2
Description
Creatinine
Timepoint
At the beginning of study and day 6
Method of measurement
Laboratory refferal
3
Description
Blood Gas ABG
Timepoint
At the beginning of study and day 6
Method of measurement
Laboratory refferal
4
Description
Duration of hospital and ICU stay
Timepoint
At the end of study
Method of measurement
day(s)
5
Description
Complete blood count (CBC)
Timepoint
At the beginning of study and day 6
Method of measurement
Laboratory refferal
6
Description
Oxygen saturation
Timepoint
At the beginning of study and day 6
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group: Medications in national guideline+ Viroherb capsule 500 mg 2 caps every 12 h + Fenugreek syrup 10 cc every 6 h
Category
Treatment - Drugs
2
Description
Control group: Medications in national guideline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Ali Asadollahi-Amin
Street address
Saadi St., Inqelab Ave.,
City
tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6672 7060
Email
amiyaneh@gmail.com
2
Recruitment center
Name of recruitment center
Ziaeian hospital
Full name of responsible person
Saeed Reza Jamali Moghaddam
Street address
20 metri Abuzar, Abuzar Sq., Ghazvin St.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
saeedjamali@yahoo.com
3
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Hadise Hosami Roodsari
Street address
Behdari St., Rah Ahan Sq.
City
Tehran
Province
Tehran
Postal code
۱۴۴۳۶۶۳۳۶۱
Phone
+98 21 5565 8500
Email
hhrudsari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
COVID-19 grant
Grant code / Reference number
99-1-147-47262
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Corner of Tabriz Ally, North Sarparast St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416663547
Phone
+98 21 8899 0835
Email
rojarahimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz Alley, North Sarparast St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416663547
Phone
+98 21 8899 0835
Fax
Email
rojarahimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz Alley, North Sarparast St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416663547
Phone
+98 21 8899 0835
Fax
Email
rojarahimi@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data from primary and secondary outcomes of patients will be available on supplementary files of published paper.
When the data will become available and for how long
Available after publishing results
To whom data/document is available
Researchers
Under which criteria data/document could be used
It has not been made a decision yet.
From where data/document is obtainable
contact via Email Address: rojarahimi@gmail.com
What processes are involved for a request to access data/document