The effect of diet on the clinical symptoms of COVID-19 outpatients with the attitude of traditional medicine
Design
The present study is a clinical trial with a control group, with parallel, randomized group, phase 3 over 80 patients
Settings and conduct
The project is being performed at a rehabilitation center for patients with coronavirus. In this study, 80 patients eligible to enter the project are divided into two groups receiving pomegranate juice and sumac and routine care. The control group (group 2) receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Outpatients with clinical symptoms of covid 19 and RT-PCR testing or chest CT positive for the disease that referred home for treatment
2- Age under 60 years 3- Relative stability of cardiovascular status
Exclusion criteria: 1- Pregnant and lactating women 2- COVID-19 patients in hospital or admitted to hospital
Intervention groups
The first group: receiving diet containing pomegranate juice and sumac The second group: receive routine treatment
Main outcome variables
Anorexia Nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043175N3
Registration date:2020-07-12, 1399/04/22
Registration timing:prospective
Last update:2020-07-12, 1399/04/22
Update count:0
Registration date
2020-07-12, 1399/04/22
Registrant information
Name
fatemeh forouzanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 7318
Email address
forouzanfarf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diet on the clinical symptoms of COVID-19 outpatients with the attitude of traditional medicine
Public title
The effect of diet based on traditional medicine on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatient patients with clinical symptoms of covid 19 and RT-PCR testing or chest CT positive for the disease that referred home for treatment.
Under 60 years of age
Relative stability of cardiovascular status
Exclusion criteria:
Pregnant and lactating women
COVID-19 patients in hospital or admitted to hospital
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The numbers from 1 to 80 is written on 80 papers and placed inside a bag. Even numbers are for intervention group and odd numbers are for control group. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number written on the paper is the base of entering to each 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
Mashhad University of Medical Sciences
Street address
Faculty of medicine, Ferdowsi complex, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.MUMS.REC.1399.313
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.02
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Anorexia Nausea
Timepoint
Every two weeks for up to a month
Method of measurement
Examination by a physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment, pomegranate juice is prescribed 3 glasses a day and 2 grams of sumac packs at noon and at night on food for four weeks.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hassan Rakhshandeh
Street address
Emam Reza Blvd, Emam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Rakhshandehh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Rakhshandehh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Rakhshandehh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant professer
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Rakhshandehh@mums.ac.ir
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Dissemination of information after completing the clinical trial and publication of the article taken from the plan
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
For research reasons
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document