The purpose of this study is evaluation the effect of crocin on inflammatory markers, oxidative damage and DNA damage in the blood of people with multiple sclerosis. Multiple sclerosis is an autoimmune disease in which the immune system attacks the nerve cells that result in nerve demyelination cause neurological disorder. Oxidative stress, free radicals and neuritis have an important role in pathogenesis of the disease. In this study that is done randomly on 40 outpatients in Farshchian hospital of Hamedan.The outpatients devide into 2 groups; the drug group and Placebo group. In the drug group patients will receive two crocin capsules per day for 28 days.The control group will receive two placebo per day, too. After one month of intervention we will measure thiol groups lipid peroxidation, total antioxidant capacity, DNA damage, IL-17, TNF-a in serum of MS patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092713194N2
Registration date:2017-04-30, 1396/02/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-30, 1396/02/10
Registrant information
Name
Akram Ranjbar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0031
Email address
a.ranjbar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-07-14, 1396/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of crocin on inflammation factors,DNA damage and biomarkers of oxidative injury in the blood of patients with multiple sclerosis
Public title
The effect of crocin on MS
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Recently diagnosed relapsing-remitting MS patients; Patients between 20-40 years old
exclusion criteria: Receiving immunomodulatory drugs such as interferons; Diabetes; Chronic disease like cardiac, liver or kidney disease; Smoking; Pregnancy and lactation; EDSS>4; Any rheumatologic disease or vasculitis; History of hypersensitivity to saffron
Age
From 20 years old to 40 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Hamedan University of Medical Sciences
Street address
Hamedan, Pazhoohesh Crossroad, In front of the Luna park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2016-08-18, 1395/05/28
Ethics committee reference number
IR.UMSHA.REC.1395.246
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis (of): NOS brain stem cord disseminated generalized
Primary outcomes
1
Description
IL-17
Timepoint
first week and fourth week
Method of measurement
ELISA
2
Description
TNF-a
Timepoint
first week and fourth week
Method of measurement
ELISA
3
Description
DNA damage
Timepoint
first week and fourth week
Method of measurement
ELISA
4
Description
Lipid peroxidation
Timepoint
first week and fourth week
Method of measurement
ELISA
5
Description
Total antioxidant capacity
Timepoint
first week and fourth week
Method of measurement
spectrophotometery
6
Description
Thiol groups
Timepoint
first week and fourth week
Method of measurement
Spectrophotometery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving 30 mg of crocin twice daily.
Category
Treatment - Drugs
2
Description
Control group: patients receiving placebotwice daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hosptal of Hamedan
Full name of responsible person
Masoud Ghiasian
Street address
Farshchian hospital, Pastor crossroad, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
In front of Luna park, Hamadan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Akram Ranjbar
Position
Associate professor/PhD of toxicology
Other areas of specialty/work
Street address
In front of Luna park, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 1591
Fax
Email
Akranjbar2015@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Ranjbar
Position
Associate Professor/ PhD of Toxicology
Other areas of specialty/work
Street address
In front of luna park, Hamedan
City
Hamedan
Postal code
Phone
00
Fax
Email
Akranjbar2015@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Forugh Khamisabadi
Position
Pharmacy student
Other areas of specialty/work
Street address
Tehran, 17 Shahrivar street, Number18
City
Tehran
Postal code
1371958444
Phone
+98 21 6678 4485
Fax
Email
F.Khamisabadi1371@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)