To investigate the efficacy of herbal drug IMFLUNA on improving the symptoms of patients with COVID-19
Design
This double-blind, phase 2 clinical trial is performed in 60 patients with symptomatic COVID-19. Patients are randomly assigned to 30 blocks of 2 patients. Each patient in the block then receives herbal or placebo capsule with code A or B. So that 30 patients are given herbal combination and 30 people are given placebo.The duration of treatment is two weeks.
Settings and conduct
Sixty eligible patients with covid-19 pneumonia referred to Sabzevar medical college Hospital will be selected and randomly divided into two groups of 30 each. The patients are given by nurse any of herbal or placebo capsule package for two weeks medication with an identification code of A or B. The package identification code are recorded in the patient's medical records. The physician, nurse, patients, data collector and who evaluate the outcome are unaware of the herbal and placebo group. Only the head of research project and expert in charge of packaging knows the type of groups. Patients are unaware of the type of group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with symptomatic COVID-19, aged 20 to 70 years who have the ability to take oral medication.
Exclusion criteria: patients with severe dyspnea require mechanical ventilation or hospitalization in intensive care units, and patients with treatment-resistant hypoxemia or those with severe underlying disease and pregnant women
Intervention groups
Intervention group: patients in this group receive two 500 mg capsules of herbal compound three times a day after post meal. Placebo group: patients in this group receive two 500 mg capsules of placebo three times a day after post meal.
Main outcome variables
blood oxygen saturation, cough, breath shortness and lung inflammation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001157N17
Registration date:2020-11-29, 1399/09/09
Registration timing:registered_while_recruiting
Last update:2020-11-29, 1399/09/09
Update count:0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of herbal drug IMFLUNA on improving the symptoms of patients with COVID-19: A placebo controled double-blind clinical study
Public title
Effects of herbal drug IMFLUNA on patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients infected with COVID-19
Confirmation of coronavirus infection with chest CT scan and PCR test
Age 20 to 70 years
Ability to take oral medication
Personal desire to participate in the project and the signing of a written consent
Exclusion criteria:
Patients with severe dyspnea
Patients with reduced level of consciousness or need hospitalization in intensive care units
Patients with swallowing disorders or possibility of aspiration of food or unable to take the drug orally
Patients with respiratory failure require mechanical ventilation
Patients with resistant hypoxemia
Patients with organ transplantation; malignant disease; treated with corticosteroids or chemotherapy
Patients with uncontrolled blood pressure, uncontrolled diabetes, cardiovascular disease and underlying respiratory disease
Pregnant women
Age
From 20 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A random number table and block randomization method is used. In this method 60 eligible patients are assigned into 30 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal medicine or placebo, so that 30 patients assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Package for herbal and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only the head of research project and expert who has done the capsules packaging are aware of the contents of the packages or what is code A or B. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Central Organization of Sabzeva University of Medical Sciences, Asadabadi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.MEDSAB.REC.1399.115
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
RA01.0
ICD-10 code description
Confirmed diagnosis of COVID-19
Primary outcomes
1
Description
Blood oxygen saturation
Timepoint
At beginning and regularly during study
Method of measurement
Pulse Oximeter
2
Description
lung inflammation
Timepoint
At beginning and end of the study
Method of measurement
Chest CT scan
3
Description
Cough
Timepoint
Night and day during the study
Method of measurement
Questionnaire
4
Description
Shortness of breath
Timepoint
Daily during the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Respiratory Rate
Timepoint
At beginning and regularly during study
Method of measurement
Respiratory Count per minute
2
Description
C-reactive protein
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
3
Description
CBC
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
4
Description
ESR
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
5
Description
BUN
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
6
Description
Creatinine
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
7
Description
K
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
8
Description
Na
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
9
Description
Body temprature
Timepoint
At beginning and daily up to end of the study
Method of measurement
Thermometer
10
Description
ALT
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
11
Description
AST
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
12
Description
ALK
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
Intervention groups
1
Description
Intervention group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the herbal drug three times a day after meals. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the Zarsan Salamat Pharmaceutical Company. The herbal drug is given as a supplement to patients daily for two weeks along with standard medications.
Category
Treatment - Drugs
2
Description
Control group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the placebo three times a day after meals. The placebo capsule contains a toasted powder is manufactured by the Zarsan Salamat Pharmaceutical Company. The placebo capsule is given as a supplement to patients daily for two weeks along with standard medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Vasei Hospital
Full name of responsible person
Fereshtah Qorat
Street address
Tohid Shahr Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4465 1300
Email
drghorat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zarsan Salamat Company
Full name of responsible person
Mehdi Khairabadi
Street address
No. 26, Nader dead end, Nader Alley, North Jamalzadeh St., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1418635642
Phone
+98 21 5779 4400
Email
Mehdy.kheirabadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zarsan Salamat Company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Afsaneh Kafash
Position
Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Infectious diseases
Street address
Mohammad Vasei Hospital, Tohid Shahr Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4465 1300
Email
vasei.h@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Fallah Huseini Hasan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Kavosh Blvd., Supa Blvd., Poleh Kordan, Karaj Qazvin Freeway
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
h.fallah@acecr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Homapharmed Company
Full name of responsible person
Mohammadreza Gholibeikian
Position
Director of R and D
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 26, Nader Alley, North Jamalzadeh St., Enghelab Square.
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Email
mgholibeikian@gmail.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
Research results are published in the form of articles.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Research results are published in the form of articles.
When the data will become available and for how long
The article will be published about six months after the completion of the project.
To whom data/document is available
There is no objection or prohibition for public use of the published article
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted.
From where data/document is obtainable
Vice Chancellor for Research, Sabzevar University of Medical Sciences
What processes are involved for a request to access data/document
To view the report of this research, after sending the request, the Vice Chancellor for Research of Sabzevar University of Medical Sciences will follow up and inform.