Study of Royal jelly effect on serum levels of IL-4, TNF- α,TGF-B, IFN-γ cytokines and its antioxidant capacity on Multiple sclerosis patients in comparison with Omega-3
The aim of this study was to compare effects of Royal jelly with Omega 3 on blood factors in multiple sclerosis patients
Design
Clinical trial with control group,Two arm parallel groups randomized double blinded trial. 60 patients with Multiple sclerosis were assigned. For randomization, the permuted block randomization will be used with quadruple blocks, In order to apply the concealment in the randomization process, unique codes will be use on drug boxes.
Settings and conduct
This study will be performed on Multiple sclerosis patients living in Ahvaz, Iran. The duration of the research is 4 weeks and the participants are divided into 2 groups randomly. double-blinding will be performed in order to avoid the bias of the subjects and the researcher and the impact on the research results. Two interventional factors including omega-3 and Royal jelly are considered for this study. Before and after treatment, patients give blood test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Multiple sclerosis patients with fatigue; No other neurological disease; No Diseases like diabetes and autoimmune diseases; No new attack in the last month Exclusion criteria: Pregnancy
Intervention groups
Control group: Interferon (main treatment) with Omega-3 capsules (each capsule contain 1 g from Nature co.) for one month, daily one after breakfast;
Intervention group: Interferon (main treatment) with Royal jelly capsules (each capsule contain 1 g from Marnys co.) for one month. one capsule daily after breakfast
Main outcome variables
serum levels of IL-4, TNF- α,TGF-B, IFN-γ cytokines and antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041466N4
Registration date:2020-09-16, 1399/06/26
Registration timing:retrospective
Last update:2020-09-16, 1399/06/26
Update count:0
Registration date
2020-09-16, 1399/06/26
Registrant information
Name
Ali Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 8149
Email address
ali.aghaei110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
2019-05-20, 1398/02/30
Actual recruitment end date
2019-08-21, 1398/05/30
Trial completion date
2019-08-21, 1398/05/30
Scientific title
Study of Royal jelly effect on serum levels of IL-4, TNF- α,TGF-B, IFN-γ cytokines and its antioxidant capacity on Multiple sclerosis patients in comparison with Omega-3
Public title
Study of Royal jelly effect on serum levels of cytokines and antioxidant capacity on Multiple sclerosis patients in comparison with Omega-3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multiple sclerosis with fatigue
No other neurological diseases
No new attack in the last month
No Diseases like diabetes and autoimmune diseases
Exclusion criteria:
Pregnancy
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com)
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocation sequence will be only known to a person who is not involved in study process; the patients and healthcare providers are all blinded.The aforementioned person will label identical sealed dug boxes as either “group1” or “group2” for each participant .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2020-01-31, 1398/11/11
Ethics committee reference number
IR.AJUMS.REC.1398.825
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Interferon Gama
Timepoint
first day of tial and one month later
Method of measurement
kits for measuring the Interferon Gama
2
Description
Transforming growth factor beta
Timepoint
first day of tial and one month later
Method of measurement
Measuring kits for measuring the TGF-B
3
Description
Tumor necrosis factor alpha
Timepoint
first day of tial and one month later
Method of measurement
Measuring kits for measuring the TNF-a
4
Description
Interlukin-4
Timepoint
first day of tial and one month later
Method of measurement
Measuring kits for measuring the IL-4
5
Description
antioxidant capacity
Timepoint
first day of tial and one month later
Method of measurement
Frap Test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Interferon (main treatment) with Omega-3 capsules (1 g daily) for one month. One capsule (made by Nature co) daily after breakfast.
Category
Treatment - Drugs
2
Description
Intervention group: Interferon (main treatment) with Royal jelly capsules (1 g daily) for one month. One capsule (made by Marnys co) daily after breakfast.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital in Ahvaz
Full name of responsible person
Amir Siahpoosh
Street address
Golestan Hospital in Ahvaz, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
golestanhospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohamad badavi
Street address
Ahvaz university of medical science, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
ِِDaneshvar st, Kianpars.
City
Ahvaz
Province
Khouzestan
Postal code
6155883964
Phone
+98 61 3333 8149
Fax
Email
ali.aghaei110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Malayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan hospital, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
malayeri.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshvar st, Kianpars.
City
Ahvaz
Province
Khouzestan
Postal code
6155883964
Phone
+98 61 3333 8149
Fax
Email
ali.aghaei110@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
Only a part of the data will be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results
To whom data/document is available
All reaserchers.
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
From where data/document is obtainable
Applicants can contact with corresponding author by e-mail
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month