The aim of this study is assessment of evaluating the therapeutic effects of Saffron on cognitive and physical symptoms in patients with Relapsing- Remitting Multiple Sclerosis, over a 12 months period. Relapsing-Remitting Multiple Sclerosis patients aged between 18-50 years and Expanded Disability Status Score (EDSS) between 0-5.5 will be included. This study will be undertaken in two centers in Iran (Sina Hospital and Brain and Spinal Injury Repair Research Center in Emam Khomeni Hospital) by presentation of 60 patients. These individuals are randomly divided into two groups; the intervention group receives Saffron (500 milligram three times a day, oral) and the control group receives placebo (three times a day, oral). To avoid any prejudgment, both patients' groups and physicians will not be informed about the type of prescribed medication (Saffron or placebo). The patients in both groups will be evaluated and compared by the number of relapses, the change in Expanded Disability Status Score (EDSS), Multiple Sclerosis Functional Composite test (MSFC) and MRI findings. In addition, In the case of any drug allergy reaction, it will be systematically recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802091859N1
Registration date:2013-02-07, 1391/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-07, 1391/11/19
Registrant information
Name
Mohammad Ali Sahraian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8571
Email address
msahrai@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice president, science and technology branch
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the saffron effect on improvement of physical and cognitive symptoms in patients with Multiple Sclerosis compared with the placebo
Public title
Saffron in treatment of Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with Relapsing- Remitting Multiple Sclerosis based on McDonald's Criteria 2.age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) 0- 5.5 4. Under treatment with Betaferon or Extavia 5. Signing consent form. -Exclusion criteria: 1. Being pregnant during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3. Allergy or hypersensitivity reaction to Saffron in the start of trial 4. Treatment with Intravenous immunoglobulin (IVIG) within six months prior to trial 5.Impaired Liver Function Tests (more than three times normal range) 6. Lack of medication more than four weeks.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Stratified Block randomization since some of the data which will be used to measure primary or secondary outcomes is gathered by physical examination, the study has been designed as a double-blind clinical trial. Knowing in which group the patient is may affect examiners’ clinical judgment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research ,Tehran University of Medical Sciences, Qods Street , Keshavarz Boulevard,Tehran .
City
Tehran
Postal code
-
Approval date
2012-01-01, 1390/10/11
Ethics committee reference number
90/d/130/1887
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Disseminated Multiple Sclerosis
Primary outcomes
1
Description
Relapse Rate
Timepoint
Before intervention and every three months after intervention
Method of measurement
Physical examination done by neurologist and EDSS
Secondary outcomes
1
Description
EDSS Expanded Disability Status Scale
Timepoint
Before intervention and every three months after intervention
Method of measurement
Physical examination done by neurologist based on revised Mc-Donald (2010)
2
Description
Number and size of plaques
Timepoint
Before intervention and every six months after intervention
Method of measurement
Magnetic resonance Imaging ( MRI )
Intervention groups
1
Description
Saffron tablet, chemical formulation the stigma of the Saffron plant, (500 milligram three times a day, oral) for 12 months, made in Drug Unit, School of Pharmacy in Tehran University of Medical Sciences in Islamic Republic Of Iran, not having generic name.
Category
Treatment - Drugs
2
Description
Placebo tablet, chemical formulation filling materials used in the preparation of pharmaceutical products (500 milligram three times a day, oral) for 12 months, made in Drug Unit, School of Pharmacy in Tehran University of Medical Sciences in Islamic Republic Of Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sina Hospital,before Hasan abad Square , Imam Khomeini Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President, Science and Technology Branch
Full name of responsible person
Mr. Tawakoli
Street address
No.162 , south Ostad Nejatolahi street,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President, Science and Technology Branch
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
Sina Hospital
Full name of responsible person
Dr.Amir Reza Azimi
Position
Neurologist
Other areas of specialty/work
Street address
Sina Hospital, before Hasan abad Square , Imam Khomeini street.
City
Tehran
Postal code
-
Phone
+98 21 6634 8571
Fax
+98 21 6634 8570
Email
amirreza_azimi@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Position
Neurologist-MS Fellowship/Associate Professor
Other areas of specialty/work
Street address
Sina Hospital, before Hasan abad Square , Imam Khomeini street.
City
Tehran
Postal code
-
Phone
+98 21 6634 8571
Fax
+98 21 6634 8570
Email
msahrai@sina.tums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Fatemeh Ghasemi Sakha
Position
researcher/master science of animal physiology
Other areas of specialty/work
Street address
Sina Hospital, before Hasan abad Square , Imam Khomeini street.
City
Tehran
Postal code
-
Phone
+98 21 6634 8570
Fax
-
Email
sakha62@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)