The effect of saffron supplementation and endurance training on the improvement of clinical and laboratory manifestations in outpatients with coronavirus
Effectiveness of endurance training and saffron supplementation in corona patients.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Corona patients, who refer to the health center of Koshksaray city, if they do not need hospitalization, will receive one of the interventions in a double-blind manner and in four groups of 10 people randomly.
Participants/Inclusion and exclusion criteria
This study will be conducted on patients with corona virus, and critical patients who need hospitalization will not be included in this study.
Intervention groups
Endurance training group + saffron supplementation, saffron supplementation group, endurance training group, control group that will not receive any intervention.
Main outcome variables
Clinical manifestations (cough, breathing rate, body temperature, recovery rate)
laboratory (inflammatory biomarkers, C-reactive protein levels)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171129037678N1
Registration date:2023-08-09, 1402/05/18
Registration timing:retrospective
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Fateme Halalkhor
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 4224 1099
Email address
fateme.halalkhor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-23, 1401/11/03
Expected recruitment end date
2023-02-22, 1401/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of saffron supplementation and endurance training on the improvement of clinical and laboratory manifestations in outpatients with coronavirus
Public title
The effect of saffron and endurance exercise in patients with coronavirus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with covid 19
Exclusion criteria:
History of allergy to saffron and its derivatives
People with liver, kidney and respiratory disorders
Lactating and pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patient receives the drug (intervention or comparison group) in sealed envelopes that have a code. Coding is done by one of the project colleagues and the doctor, evaluator and patient do not know anything.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug (intervention or comparison group) in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the doctor, evaluator and patient do not know anything.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
No. 3, Fifth Alley, MirEmad St., Motahari St., Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR/SSRI.REC.2023.14658.2153
Health conditions studied
1
Description of health condition studied
coronavirus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Cough
Timepoint
Before and 14 days after the start of treatment
Method of measurement
Physical examination
2
Description
breathing rate
Timepoint
Before and 14 days after the start of treatment
Method of measurement
Physical examination
3
Description
Body temperature
Timepoint
Before and 14 days after the start of treatment
Method of measurement
Physical examination
4
Description
Speed of improvement
Timepoint
Before and 14 days after the start of treatment
Method of measurement
Physical examination
5
Description
Inflammatory biomarkers
Timepoint
Before and 14 days after the start of treatment
Method of measurement
blood test
6
Description
The amount of C-reactive protein
Timepoint
Before and 14 days after the start of treatment
Method of measurement
blood test
Secondary outcomes
1
Description
Serum level of specific IgG antibody for N and S antigens
Timepoint
One month after training
Method of measurement
Eliza method
Intervention groups
1
Description
Intervention group: patients in this group, in addition to drug treatment according to the national guidelines for the new coronavirus, They receive saffron supplements for 14 days. (400 mg equivalent to 5.7 mg per kilogram of body weight per day)
Category
Treatment - Other
2
Description
Control group: Patients in this group receive drug treatment according to the national guidelines for the new coronavirus.
Category
Placebo
3
Description
Intervention group: Patients in this group, in addition to the medical treatment according to the national guidelines for the new coronavirus, two weeks of endurance exercise (12 sessions2 hours, four sessions per week, aerobic exercise with an intensity of 65% of the maximum heart rate).
Category
Treatment - Other
4
Description
Intervention group: Patients in this group receive saffron supplement for 14 days, in addition to the medical treatment according to the national guidelines for the new coronavirus. (400 mg equal to 5.7 mg per kilogram of body weight per day) plus two weeks of endurance training (12 sessions 2 hours, four sessions per week, aerobic exercise with an intensity of 65% of maximum heart rate).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Koshksaray Health Center
Full name of responsible person
Mohammad Taheri
Street address
Koshksaray, Qaraje Mohammad Road
City
Koshksaray
Province
East Azarbaijan
Postal code
5447134581
Phone
+98 41 4214 0499
Email
fateme.halalkhor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Vice President of Research and Technology of Mohaghegh Ardabili University
Street address
university street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 0000
Email
info@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
Proportion provided by this source
1
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
University of Tabriz
Full name of responsible person
Fateme Halalkhor
Position
MSc. Student in Sport Nutrition, University of Tabriz
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Physical Education and Sport Sciences, University of Tabriz, 29 Bahman BLVD, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5447135411
Phone
+98 41 4224 1099
Fax
Email
fateme.halalkhor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Fateme Halalkhor
Position
MSc. Student in Sport Nutrition, University of Tabriz
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Physical Education and Sport Sciences, University of Tabriz, 29 Bahman BLVD, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5447135411
Phone
+98 41 4224 1099
Fax
Email
fateme.halalkhor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Fateme Halalkhor
Position
MSc. Student in Sport Nutrition, University of Tabriz
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Physical Education and Sport Sciences, University of Tabriz, 29 Bahman BLVD, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5447135411
Phone
+98 41 4224 1099
Fax
Email
fateme.halalkhor@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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
After completing the plan
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research
From where data/document is obtainable
Email address of the researcher
What processes are involved for a request to access data/document