Efficacy of Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Patients Admitted to Ganjavian Hospital in Dezful with Mild to Moderate Stages: A Randomized Clinical Trial
Efficacy of Palm Leaf Extract (Phoenix dactylifera) in Patients with New Coronavirus (COVID-19) in Weak to Moderate Stages.
Design
100 patients who will be randomly assigned to two groups of 50 people (intervention group and control group) will be selected from patients referred to Ganjavian hospital who will be diagnosed by the physician at the initial visit of COVID-19 and volunteer to participate in the project.
Settings and conduct
This study was a double-blind randomized controlled clinical trial. The physician, nurses and the volunteer patient are not aware of the type of prescribed drug. 100 (men and women of different ages) from patients with COVID-19, referred to Ganjuyan Hospital in Dezful who are in mild or moderate stage, will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients >12 years of age (male/female) with mild to moderate disease, which can be determined by clinical criteria (dry cough, fever and dyspepsia) and para clinical indices (PaO2, PCR, CT Scan, CRP, CBC) with COVID-19; signing consent by persons or the assistant of patients.
Exclusion criteria: dissatisfaction of patients or patients' assistants; allergic reactions from the use of palm extract; critically ill patients or cases where the doctor may not recommend the use of intervention.
Intervention groups
Patients in the intervention groups take 5 ml of Phoenix (solution containing palm leaf extract) 5 times a day.
Patients in the control groups take 5 ml of Phoenix placebo (solution without palm leaf extract) 5 times a day.
Main outcome variables
Palm Leaf Extract
CT scan
Body temperature
CRP
PCR
PaO2
ESR
White Blood Cell Count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201015049036N1
Registration date:2020-11-27, 1399/09/07
Registration timing:retrospective
Last update:2020-11-27, 1399/09/07
Update count:0
Registration date
2020-11-27, 1399/09/07
Registrant information
Name
Mohammad Dorchin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4255 6011
Email address
dr.dorchin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-12, 1399/06/22
Expected recruitment end date
2020-11-12, 1399/08/22
Actual recruitment start date
2020-09-18, 1399/06/28
Actual recruitment end date
2020-11-16, 1399/08/26
Trial completion date
2020-11-16, 1399/08/26
Scientific title
Efficacy of Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Patients Admitted to Ganjavian Hospital in Dezful with Mild to Moderate Stages: A Randomized Clinical Trial
Public title
Efficacy of Date Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Hospitalized in Ganjavian Hospital in Dezful
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients >12 years of age (male/female) with mild to moderate disease, which can be determined by clinical criteria (dry cough, fever and dyspnea) and paraclinical indices PO2, PCR, CT Scan, CRP, CBC
Signing the form of consent by persons >18 years of age or the guardians of the under-aged patients
Exclusion criteria:
Dissatisfaction of patients or the patients' guardians
Any allergic reactions from the use of the palm extract
Critically ill patients or the cases where the physician in chief may not recommend this intervention for hospitalized patients
Age
From 12 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria and with respect to their genders will be assessed clinically. The patients will be divided into to two groups randomly: drug recipients and placebo recipients. The patients will be assigned certain codes, and only the pharmacy team will be aware of the nature of the two groups. The physician in chief, the nurses and the patients are not aware of whether they are receiving drug or placebo.placebo of the syrup.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients use drugs and placebo that are in exactly the same containers and labels but have different codes, and except for the pharmacy team, none of the treating physicians, nurses, and patients are aware of those codes.
Placebo
Used
Assignment
Parallel
Other design features
The study will be conducted in cooperation with infectious and internal specialists and pulmonary specialists.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Dezful University of Medical Sciences
Street address
Vice Chancellor for rsearch, Dezful University of Medical Sciences, Azadegan alley, Andimeshk road to Dezful
City
Dezful
Province
Khouzestan
Postal code
6461643993
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.DUMS.REC.1399.037
Health conditions studied
1
Description of health condition studied
Coronavirous (COVID19)
ICD-10 code
U07.1
ICD-10 code description
Corona virus infection, unspecified
Primary outcomes
1
Description
Lung infection
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
CT Scan
2
Description
Virus diagnosis
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
PCR
3
Description
Fever
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
Thermometer
4
Description
PaO2: oxygen pressure in arterial blood
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
Record the degree of oxygen pressure
5
Description
CRP: reactive protein in blood for detect the inflammation
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
Comparison with normal standard range in blood test
6
Description
ESR: erythrocyte sedimentation rate used to monitor inflammatory diseases
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
Comparison with normal standard range in blood test
7
Description
WBC: white blood cell
Timepoint
At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment
Method of measurement
Comparison with normal standard range in blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment- medicine: Phoenix medicine (contains hydro alcoholic solution, Phoenix leaf extract, Vitamin C and Strawberry flavoring) 5 times/day, each time 5 ml.
Category
Treatment - Drugs
2
Description
Control group: treatment-placebo: contains hydro alcoholic solution, Vitamin C , Strawberry flavoring, without Phoenix leaf extract) 5 times/day, each time 5 ml.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ganjavian Hospital
Full name of responsible person
Mohammad Dorchin
Street address
Gangavian Hospital, Andimesh road to Dezful
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 2040
Fax
+98 61 4242 7159
Email
bbd@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Dr. Maysam Mard Soltani
Street address
Vice Chancellor for Research, Dezful University of Medical Sciences
City
ِDezful
Province
Khouzestan
Postal code
6461643993
Phone
+98 61 4255 6011
Fax
+98 61 4242 7160
Email
research@dums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mohammad Dorchin
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
No.440 west Farhang 2 Ave.
City
Dezful
Province
Khouzestan
Postal code
6461896973
Phone
+98 61 4255 6011
Fax
+98 61 4242 7160
Email
dr.dorchin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mohammad Dorchin
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
No.440 west Farhang2 Ave.
City
Dezful
Province
Khouzestan
Postal code
6461896973
Phone
+98 61 4255 6011
Fax
+98 61 4242 7160
Email
dr.dorchin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mohammad Dorchin
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
No. 440, west Farhang 2 Ave.
City
Dezful
Province
Khouzestan
Postal code
6461896973
Phone
+98 61 4255 6011
Fax
+98 61 4242 7160
Email
dr.dorchin@gmail.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
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be collected by an epidemiologist's cooperation after the jamming.
When the data will become available and for how long
Two months.
To whom data/document is available
Dr Gholamreza Amin , Ghasem Takdehghan؛ Dr. Mohammad Dorchin
Under which criteria data/document could be used
Only for data collection and analysis.
From where data/document is obtainable
Dr. Mohammad Dorchin
What processes are involved for a request to access data/document
Written request and approval of the project's executive and the main colleagues of the project (Dr. Gholamreza Amin and Mr. Ghasem Takdehghan)