The effect of almond porridge, grape juice and chickpea juice on weakness and duration of hospitalization and clinical symptoms due to covid 19
Design
This is a single-center double-blind, placebo-controlled randomized trial with 160 (80 in each group) participants.
Settings and conduct
patients with Covid-19 that are hospitalized at AJA hospital will be randomized into treatment and placebo groups and will be assessed at baseline and 3-months and 6-months visits. The primary investigator of the study, who will not be involved in diagnosis and follow-up, will carry out the randomization and allocation using permuted block randomization with blocks of size 4. Treatment allocations will be concealed using opaque envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) age between 18 and 65 years 2) Positive PCR test and lung involvement on CXR and positive clinical signs 3) Candidate for inpatient treatment
Exclusion criteria: 1) Respiratory distress 2) Hospitalization in the intensive care unit or tracheal intubation
Intervention groups
Both study and control groups will receive the same food and covid-19 treatments (standard hospital regimen).
During the hospital stay, in addition to the standard hospital regimen, we give the patient a mixture of almond porridge and grape juice between meals at 10 o'clock during the hospital stay. We also give chickpea juice to the patient in the 4 o'clock snack.
Main outcome variables
Hospital stay
The Fatigue Assessment Scale (FAS) for the assessment of fatigue severity
SF-36 questionnaire for the assessment of the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220228054150N1
Registration date:2022-04-08, 1401/01/19
Registration timing:registered_while_recruiting
Last update:2022-04-08, 1401/01/19
Update count:0
Registration date
2022-04-08, 1401/01/19
Registrant information
Name
Seyed Mahdi Mirghazanfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 6350
Email address
smmirghazanfari@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of almond porridge, grape extract, and pea syrup on reduction of recovering period in patients with Covid-19
Public title
Almond porridge, grape extract, and pea syrup for treatment of Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Conscious consent to participate in the study
positive PCR test and lung involvement on CT scan and positive clinical signs including fever greater than 38 degrees or hot flashes with at least one of the symptoms of dry cough, 24 Respiratory rate per minute, headache or body aches, weakness and lethargy, anosmia (olfactory disorder) or taste disturbances and anorexia Absence of respiratory distress
Candidates for hospitalization
Exclusion criteria:
admission to the intensive care unit
patients with intubation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be equally randomized into treatment or control groups in a 1:1 ratio. A specific random code will be assigned to each patient using the Microsoft Office Excel software. The primary investigator of the study, who will not be involved in diagnosis and follow-up, will carry out the randomization and allocation using permuted block randomization with blocks of size 4. Treatment allocations will be concealed using opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocations will be kept in confidential and opaque envelopes and will be exposed at the end of the trial. Placebo will be completely indistinguishable from treatment. Randomizations, drug administration, rating, data entry, and statistical analyses will be conducted by separate individuals that are blinded to drug allocations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA university of medical sciences, Etemadzadeh st, West Fatemi st,
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.AJAUMS.REC.1400.322
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
The Fatigue Assessment Scale (FAS) score
Timepoint
0, 3, 6 months after treatment
Method of measurement
The Fatigue Assessment Scale (FAS)
2
Description
hospital stay
Timepoint
after the initiation of treatment till discharge from hospital
Method of measurement
heath records
Secondary outcomes
1
Description
ESR, CRP
Timepoint
during addmision
Method of measurement
laboratory measurement using electroimmunoassay (EIA)
Intervention groups
1
Description
Intervention group: A mixture of almond porridge and grape juice (containing 25 grams of almonds and 8 cc of grape juice) is given to the patient in a disposable container in the snack at 10 o'clock and given to the patient during the hospital stay. Also in the snack at 16 o'clock, chickpeas (containing 30 grams of chickpeas) will be given in a disposable container during the hospital stay.
Category
Treatment - Drugs
2
Description
The placebo will be similar to the intervention in terms of shape, taste, color and smell and will be given to the patient at 10 and 16 o'clock.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AJA university of medical sciences hospital
Full name of responsible person
Seyed Mehdi Mirghazanfari
Street address
AJA university of medical sciences, Etemadzadeh st, West Fatemi st,
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7922
Email
smmirghazanfari@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirghazanfari
Street address
AJA university of medical sciences, Etemadzadeh st, West Fatemi st,
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7922
Email
smmirghazanfari@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mirghazanfari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
AJA university of medical sciences, Etemadzadeh St, west Fatemi St, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Fax
Email
smmirghazanfari@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mirghazanfari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
AJA university of medical sciences, Etemadzadeh St, west Fatemi St, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Fax
Email
smmirghazanfari@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mirghazanfari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
AJA university of medical sciences, Etemadzadeh St, west Fatemi St, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Fax
Email
smmirghazanfari@ajaums.ac.ir
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