To investigate the effects of herbal compound IMFLUNA on improving the symptoms of patients with covid-19 pneumonia
Design
This double-blind, phase 2 clinical trial is performed in 60 patients with covid-19 pneumonia. 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 compound 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 Baqiyatallah 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 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 covid-19 pneumonia, 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
Main outcome variables are blood oxygen saturation, respiratory rate and lung inflammation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001157N16
Registration date:2020-04-08, 1399/01/20
Registration timing:registered_while_recruiting
Last update:2020-04-08, 1399/01/20
Update count:0
Registration date
2020-04-08, 1399/01/20
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
2020-03-30, 1399/01/11
Expected recruitment end date
2020-05-31, 1399/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of IMFLUNA herbal compound on the improvement of covid-19 pneumonia symptoms in patients referred to Baqiyatallah Hospital
Public title
Effect of IMFLUNA herbal compound on covid-19 pneumonia symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients infected with symptomatic covid-19 pneumonia virus
Confirmation of coronavirus infection with chest CT scan and PCR test
Age 20 to 70 years who have the 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
Investigator
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)
Triple 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 expert who has done the capsules packaging is 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
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Vanak square, Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1484958693
Approval date
2020-03-29, 1399/01/10
Ethics committee reference number
IR.BMSU.REC.1399.036
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
Respiratory Rate
Timepoint
At beginning and regularly during study
Method of measurement
Respiratory Count
3
Description
lung inflammation
Timepoint
At beginning and end of the study
Method of measurement
Chest CT scan
Secondary outcomes
1
Description
C-reactive protein
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
2
Description
CBC
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
3
Description
ESR
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
4
Description
BUN
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
5
Description
Creatinine
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
6
Description
K
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
7
Description
Na
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
8
Description
Cough
Timepoint
At beginning and regularly during the study
Method of measurement
Count
9
Description
Fever
Timepoint
At beginning and regularly during the study
Method of measurement
Termometer
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 compound three times a day after meals. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the HomaPharmed Pharmaceutical Company. The herbal capsule is given as a supplement to patients 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 HomaPharmed Pharmaceutical Company. The placebo capsule is given as a supplement to patients for two weeks along with standard medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Mohtashami
Street address
Vanak square, Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1484958693
Phone
+98 21 8806 8923
Email
rmohtashami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
HomaPharmed Company
Full name of responsible person
Morteza Khairabadi
Street address
Enghelab Square, North Jamalzadeh St., Nader Alley., No 26
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Fax
+98 21 6690 8071
Email
info@homapharmed.com
Web page address
http://www.homapharmed.com
Grant name
Agreement
Grant code / Reference number
17/1/1399- 5/340/س
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
HomaPharmed 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
Institute of Medicinal Plants
Full name of responsible person
Fallah Huseini Hasan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kavosh Blvd., Supa Blvd., Poleh Kordan
City
karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Email
h.fallah@acecr.ac.ir
Person responsible for scientific inquiries
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
Enghelab Square, North Jamalzadeh St., Nader Alley., No 26
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Fax
+98 21 6690 8071
Email
mgholibeikian@gmail.com
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
Enghelab Square, North Jamalzadeh St., Nader Alley., No 26
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Email
mgholibeikian@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