Investigating the effect of "nokhod-ab" on the recovery of patients with coronavirus
Design
The present study is a clinical trial with a control group, with parallel, randomized group, phase 3 over 40 patients
Settings and conduct
The project is being performed at a rehabilitation center for patients with coronavirus. In this study, 40 patients eligible to enter the project are divided into two groups receiving nokodab and routine care. Recipients receive 80 cc of nokodab daily for half an hour before meals for 2 weeks.The control group does not take.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age over 18 year
2-Corona positive test
3-Both men and women
4-Recovery stage
Exclusion criteria:
1-Severe kidney disease
2-Liver failure
3- have gout
4-High uric acid
5-Taking medications that induced fatigue
Intervention groups
The first group: receiving nokodab
The second group: receive routine treatment
Main outcome variables
Score of Fatigue Severity based on "Visual Analogue Fatigue Scale"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046144N2
Registration date:2020-05-21, 1399/03/01
Registration timing:prospective
Last update:2020-05-21, 1399/03/01
Update count:0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Bahareh Ahadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3562
Email address
ahadi.b@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-31, 1399/03/11
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a Persian diet"nokhod-ab" on corona virus-related fatigue in patients living in accommodation
Public title
Effects of nokhod-ab on fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18year
Corona positive test
Both men and women
Recovery stage
Exclusion criteria:
Severe kidney disease
Liver failure
Having gout
High uric acid
Taking medications that induce fatigue
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The numbers from 1 to 40 is written on 40 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
committee semnan university of Medical Sciences
Street address
Basij Blvd, University Headquarters
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.SEMUMS.REC.1399.031
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
Score of Fatigue Severity "Visual Analogue Fatigue Scale"
Timepoint
Before the intervention,after the intervention(2 weeks later)
Method of measurement
Using Visual Analogue Fatigue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administrating 80 cc"nokhod-ab" tree times a day for two weeks
Category
Treatment - Drugs
2
Description
Control group: They do not receive treatment. Follow this group only to complete the questionnaires at specific intervals
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Recovery of Kosar Hospital in Semnan
Full name of responsible person
Bahareh Ahadi
Street address
Basij Blvd, Kosar Hospital
City
Semnan
Province
Semnan
Postal code
3519667311
Phone
+98 23 3344 1022
Email
drahadi89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Parviz Kokhaei
Street address
Basij Blvd,University Headquarters
City
Semnan
Province
Semnan
Postal code
351973473
Phone
+98 23 3344 1021
Fax
+98 23 3346 1580
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Bahareh Ahadi
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Basij Blvd،semnan،Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1021
Fax
+98 23 3344 8999
Email
drahadi89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Gohari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Basij Blvd,University Headquarters
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1021
Fax
+98 23 3344 8999
Email
aligohari@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahareh Ahadi
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Basij Blvd, University Headquarters
City
Semnan
Province
Semnan
Postal code
982333448999
Phone
+98 23 3344 1021
Fax
+98 23 3344 8999
Email
drahadi89@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
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 printing 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