The purpose of this study is to investigate the effect of 6 weeks of aerobic training and royal jelly consumption on total antioxidant capacity and glutathione peroxidase in patients with multiple sclerosis.
Design
A clinical trial with the control group, parallel, single-blind, randomized, with a predicted sample size of 60 and Phase 3 trial
Settings and conduct
This study will be performed on multiple sclerosis patients living in Zahedan, Iran. The duration of the research is 6 weeks and the participants are divided into four groups randomly. Single-blind blindness 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 exercise and Royal jelly are considered for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Multiple sclerosis patients: Expanded Disability Status Scale (EDSS) between 0-4
No supplement
No cardiovascular disease
Exclusion criteria:
Non- multiple sclerosis Patients
Multiple sclerosis patients: EDSS more than 4
Use of pharmaceutical supplements
Cardiovascular disease
Intervention groups
First intervention group: Exercise and Royal jelly; Aerobic exercise and Royal jelly have been selected as interventionists of this group.
Second intervention group: Exercise and placebo; Aerobic exercise has been selected as the intervention of this group. Of course, the placebo will also be used.
Third intervention group: Royal jelly. In this group, Royal jelly is an intervention agent.
Control group: Placebo; The placebo will be used in the control group.
Main outcome variables
Study of total antioxidant capacity changes; Study of Glutathione Peroxidase Changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040073N1
Registration date:2018-11-10, 1397/08/19
Registration timing:prospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Majid Vahidian-Rezazadeh
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6107
Email address
vahidian@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 6 weeks aerobic ergometer and royal jelly on total antioxidant capacity and glutathione peroxidase in multiple sclerosis patients
Public title
The effect of exercise and royal jelly on total antioxidant capacity and glutathione peroxidase in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis patients: Expanded Disability Status Scale (EDSS) between 0-4
No use of any supplement
Lack of cardiovascular disease
Exclusion criteria:
Non-MS Patients
Multiple sclerosis patients: EDSS more than 4
Use of pharmaceutical supplements
With cardiovascular disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization Tool: Sealed Envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants:
The first and second intervention groups will have joint physical activity, but they will not be aware of the royal jelly and placebo in the study.
The third intervention group and the control group will not be aware of the royal jelly and placebo in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Ali Ebn Abitaleb Hospital, Salamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.219
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
Total antioxidant capacity changes
Timepoint
Blood sampling at the beginning of the study (24 hours before the intervention) and 24 hours after the last session of the research protocol
Method of measurement
"Total antioxidant capacity" test kit
2
Description
Glutathione peroxidase Changes
Timepoint
Blood sampling at the beginning of the study (24 hours before the intervention) and 24 hours after the last session of the research protocol
Method of measurement
"Glutathione peroxidase" test kit
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Exercise and Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral
Category
Treatment - Other
2
Description
Second intervention group: Exercise and placebo Name of the used substance: Placebo Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral
Category
Treatment - Other
3
Description
Third intervention group: Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and its concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral
Category
Treatment - Other
4
Description
Control group: Placebo Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Ali Moghtaderi
Street address
Ali Ebn Abitaleb Hospital, Salamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
moghtaderi@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dor Mohammad Kordi
Street address
Deputy of Research, Central Organization, University of Sistan and Baluchestan, Daneshgah Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6246
Email
dor_kordi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
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
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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