Protocol summary

Summary
This study aimed to determine the effect of crocin saffron on biomarkers of oxidative stress in the saliva and urine of patients with multiple sclerosis. The study was a randomized controlled trial study design. The inclusion criteria contains recently diagnosed relapsing-remitting MS patients and aged between 20 and 40 years. Exclusion criteria contains history of hypersensitivity to saffron, diabetes, underlying chronic illnesses including liver disease, kidney, lung and heart, smoking, pregnancy and lactation, any rheumatologic disease or vasculitis. In this study, 40 patients referred to the Farshchian hospital of Hamedan (in succession), were randomly assigned to the intervention and placebo groups with respect concealment of allocation will be allocated. Intervention group consume 30 mg capsule of crocin per day (15 mg twice daily) and placebo groups (two capsules per day) for 15 days. In this study, catalase enzyme, total antioxidant capacity of saliva, Thiol groups of saliva, lipid peroxidation, total antioxidant capacity of urine, Thiol levels of urine, before the study and at the end of the treatment period, is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122013194N3
Registration date: 2017-03-05, 1395/12/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-05, 1395/12/15
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
Not yet recruiting
Funding source
Vice chancellor for research, Hamedan university of medical sciences
Expected recruitment start date
2051-03-20, 1429/12/29
Expected recruitment end date
2071-03-20, 1449/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of crocin on biomarkers of oxidative stress in the Saliva and Urine of patients with multiple sclerosis
Public title
The effect of crocin in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Recently diagnosed relapsing-remitting MS patients; Patients between 20-40 years old exclusion criteria: Receiving corticosteroids before the study; Receiving immunomodulatory drugs such as interferons before the study; Diabetes; Underlying chronic illnesses including liver disease, kidney, lung and heart; Smoking; Pregnancy and lactation; Any rheumatologic disease or vasculitis; History of hypersensitivity to saffron
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
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
ethic Committee of hamedan university of medical sciences
Street address
hamedan university of medical sciences
City
hamedan
Postal code
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.UMSHA.REC.1395.375

2

Ethics committee
Name of ethics committee
Hamedan University Research Ethics Committee of Medical Sciences
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.349

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G36
ICD-10 code description
Other acute disseminated demyelination

2

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

3

Description of health condition studied
Multiple sclerosis
ICD-10 code
G37
ICD-10 code description
Other demyelinating diseases of central nervous system

Primary outcomes

1

Description
Total antioxidant capacity of urine
Timepoint
Before and after intervention
Method of measurement
spectrophotometer TPTZ reagent in a 593 nm

2

Description
Catalase Enzyme
Timepoint
Before and after intervention
Method of measurement
According U / ml using Spectrophotometry

3

Description
Total antioxidant capacity of saliva
Timepoint
Before and after intervention
Method of measurement
According U / ml using Spectrophotometry

4

Description
Thiol groups of saliva
Timepoint
Before and after intervention
Method of measurement
According U / ml using Spectrophotometry

5

Description
Lipid peroxidation
Timepoint
Before and after intervention
Method of measurement
spectrophotometer TBA reagent in a 532 nm

6

Description
Thiol levels in urine
Timepoint
Before and after intervention
Method of measurement
HU method

Secondary outcomes

empty

Intervention groups

1

Description
In the control group a placebo (a capsule that is not crocin of saffron, but the patients are not told anything about it) two capsules a day for 15 days to receive oraly.
Category
Placebo

2

Description
In the intervention group crocin saffron capsules of 30 mg per day (15 mg twice daily) given for 15 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr. Masoud Ghiasian
Street address
Farshchian Hospital
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
Hamedan University of Medical Sciences
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
Dr. Akram Ranjbar
Position
PhD in Toxicology
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
00
Fax
Email
Akranjbar1389@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Akram Ranjbar
Position
PhD in Toxicology
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
00
Fax
Email
Akranjbar1389@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Akram Ranjbar
Position
PhD in Toxicology
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
00
Fax
Email
Akranjbar1389@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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