Investigation the effect of trehalose on fatigue of a patient with MS
Design
This trial is a before-after trial without a control group and will be performed by participation of only one eligible patient.
Settings and conduct
This study will be conducted in Ghaem Hospital in Mashhad. In the current trial, one MS patient who meets the inclusion criteria, will receive IV trehalose (15 gr per week) for 12 weeks. The mentioned outcomes will be compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of multiple sclerosis (MS), Suffering from fatigue, Satisfaction for participation in the research project, Living in Mashhad. Exclusion Criteria: Willingness to withdraw from the study, Exacerbation of manifestations of MS after each IV administration, Under treatment of depression.
Intervention groups
Intervention group: IV Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical Co.
Main outcome variables
Primary outcome: Fatigue Score by Modified Fatigue Impact Scale (MFIS). Secondary outcomes: Quality of life by European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), Depression and Anxiety by Hospital Anxiety and Depression Scale (HADS), Ability to walk by Multiple Sclerosis Walking Scale-12 (MSWS-12), Inflammatory markers including C-reactive protein, gene expression of TNFα, IFNγ, IL10, IL16, IL17). All the mentioned outcomes will be assessed at baseline and after 3 months.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N14
Registration date:2025-06-19, 1404/03/29
Registration timing:prospective
Last update:2025-06-19, 1404/03/29
Update count:0
Registration date
2025-06-19, 1404/03/29
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intravenous Trehalose on the fatigue and performance of a patient with Multiple Sclerosis
Public title
The effect of intravenous trehalose on Fatigue in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of multiple sclerosis (MS)
Suffering from fatigue
Satisfaction for participation in the research project
Living in Mashhad
Exclusion criteria:
Willingness to withdraw from the study
Exacerbation of manifestations of MS after each IV administration
Under treatment for depression
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2025-04-26, 1404/02/06
Ethics committee reference number
IR.MUMS.REC.1404.067
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
Multiple S
ICD-10 code description
G35
Primary outcomes
1
Description
Fatigue score
Timepoint
At baseline and after 12 weeks
Method of measurement
Using Modified Fatigue Impact Scale (MFIS)
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline and after 12 weeks
Method of measurement
Using European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
2
Description
Depression and anxiety
Timepoint
At baseline and after 12 weeks
Method of measurement
Using Hospital Anxiety and Depression Scale (HADS)
3
Description
Ability to walk
Timepoint
At baseline and after 12 weeks
Method of measurement
Multiple Sclerosis Walking Scale-12 (MSWS-12)
4
Description
Inflammatory markers including C-reactive protein, gene expression of TNFα, IFNγ, IL10, IL16, IL17)
Timepoint
At baseline and after 12 weeks
Method of measurement
Blood Sample
Intervention groups
1
Description
Intervention group: IV Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical Co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Maryam Emadzadeh
Street address
Ahmad Abad Blvd., Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 915 558 4885
Email
maryamemadzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 7403
Email
maryamemadzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amihossein Sahebkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
sahebkara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 7403
Email
maryamemadzadeh@yahoo.com
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