This study as a before-after study, aims to investigate the effect of saffron syrup on reducing fatigue in patients with multiple sclerosis (MS). So the sample size of 30 people who have had a history of the disease for at least 6 months and do not use anti-depressant drugs will be selected as available and will be evaluated according to the Fatigue Severity Scale (FSS). Patients who have moderate to severe fatigue based on this scale will be included in the study. Participants in this study take a tablespoon of saffron syrup every 8 hours for two months. After 60 days of drug administration, patients are again evaluated for fatigue to determine how effective the drug is in reducing their fatigue.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061226667N6
Registration date:2017-08-04, 1396/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Ali Jadidi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3508
Email address
jadidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2018-04-17, 1397/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Saffron syrup on fatigue severity in patient with multiple sclerosis
Public title
Effect of saffron syrup on fatigue severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a history of MS for 6 months; Age 15 to 60 years; The desire to enter the study; Not pregnant; Not having diabetes. Exclusion criteria: Unwillingness to continue the study; Use of antidepressants; Use of other effective drugs for the relief of fatigue (Ritalin, Pamolin and Amantadine); Treated by other methods such as physical therapy and occupational therapy.
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij square, Taleghani Avenue.
City
Arak
Postal code
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
IR.ARAKMU.REC.1396.68
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
Fatigue severity
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Questionnaire of Fatigue Severity Scale (FSS)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Take a tablespoon of saffron syrup every 8 hours for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Ali Khan Mohammadi
Street address
Sardasht Square, Taleghani Street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Street address
Sardasht Square, Taleghani Street, Arak University of Medical Sciences, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Reza Rezai Ashtiani
Position
Neuorologist
Other areas of specialty/work
Street address
Amir Al-Momenin Haspit, Basij Square, Taleghani Avenue ,Arak
City
Arak
Postal code
Phone
+98 86 3222 2005
Fax
Email
dr.shtiani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyyed Amir Hossein Latifi
Position
PhD of Traditional Medicine
Other areas of specialty/work
Street address
Arak University of Medical Science, Basij Square, Taleghani Avenue, Arak
City
Arak
Postal code
Phone
+98 86 3417 3508
Fax
Email
seiedalatifi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Khan Mohammadi
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Basij Square, Taleghani Street, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3508
Fax
Email
alikhan.nurse@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)