Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000610932
Ethics application status
Approved
Date submitted
19/05/2011
Date registered
14/06/2011
Date last updated
14/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic effect of saffron on cognitive function in multiple sclerosis patients
Scientific title
Therapeutic effect of saffron compared to a placebo on cognitive function and depression in definitive multiple sclerosis patients
Secondary ID [1] 260077 0
Nil
Universal Trial Number (UTN)
U1111-1121-1162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 265755 0
Cognitive dysfunction 267913 0
Depression 267914 0
Condition category
Condition code
Neurological 265894 265894 0 0
Multiple sclerosis
Alternative and Complementary Medicine 265895 265895 0 0
Herbal remedies
Mental Health 268124 268124 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
saffron capsule 30mg/kg/day for 16 weeks
Intervention code [1] 264499 0
Treatment: Other
Comparator / control treatment
lactose capsule for 16 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 266665 0
Beck-2 depression score
Timepoint [1] 266665 0
at baseline and 16 weeks after intervention commencement
Primary outcome [2] 266791 0
BRB-N memory and cognitive test
Timepoint [2] 266791 0
at baseline and 16 weeks after intervention commencement
Secondary outcome [1] 276159 0
possible side effect will be assessed by patient interview:
nausea
drowsiness
change in appetite
allergic reaction
Timepoint [1] 276159 0
two weeks after intervention commencement

Eligibility
Key inclusion criteria
Definitive diagnosed MS with MC-donald 2010 criteria
3 of 5 memory domain involvement(BRB-N test)
Do not use any treatment for memory function up to 3 month before intervention
Ability to do the test and fill the questionnaire him/herself
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other cause of cognitive impairment other than MS
MS attack in previous month before intervention
Severe depression according to Beck-2 in the beginning of the intervention
Alcohol or drug abuse among the study
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done by person who is not involved in enrolling the patients and write intervention group(A or B) in sealed opaque envelopes after determining its sequence. Thereafter people who are undertaking enrolling, after checking the inclusion and exclusion criteria, open the envelope to determine the intervention group of each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each group(drug/placebo) named A or B by someone who is not involved in enrolling, evaluation and analysis. According to randomization table, sequence of block will be defined.
(Permuted block randomization)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3434 0
Iran, Islamic Republic Of
State/province [1] 3434 0

Funding & Sponsors
Funding source category [1] 264978 0
Commercial sector/Industry
Name [1] 264978 0
green plants of life
Country [1] 264978 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of medical science
Address
poorsina St, Enghelab Sq, tahran, iran
postal/ZIP: 1417613151
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 264068 0
Individual
Name [1] 264068 0
Masood Nabavi
Address [1] 264068 0
Mostafa Khomein hospital, Italia ST, Tehran, Iran

Postal/ZIP: 141665185
Country [1] 264068 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267088 0
Ethic committee of Tehran University of medical science
Ethics committee address [1] 267088 0
poorsian St, Enghelab Sq, tahran, iran
postal/ZIP: 1417613151
Ethics committee country [1] 267088 0
Date submitted for ethics approval [1] 267088 0
Approval date [1] 267088 0
Ethics approval number [1] 267088 0

Summary
Brief summary
Memory dysfunction is a common undesirable symptom in Multiple sclerosis. According to the proved effect of saffron in memory deficit of Alzheimer disease, we hypothesis that it may be helpful for MS patients too.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32546 0
Address 32546 0
Country 32546 0
Phone 32546 0
Fax 32546 0
Email 32546 0
Contact person for public queries
Name 15793 0
Sadeghi Naini, Mohsen
Address 15793 0
Num29, Karimi Alley, Arash Blv, Zafar St.
Tehran
Iran
Postal/ZIP: 1916649411
Country 15793 0
Iran, Islamic Republic Of
Phone 15793 0
+989124934734
Fax 15793 0
Email 15793 0
[email protected]
Contact person for scientific queries
Name 6721 0
Nabavi, seyed masoud
Address 6721 0
Mostafa Khomeini Hospital
Vesal St., Italia St.
Tehran
Iran
Postal/ZIP 141665185
Country 6721 0
Iran, Islamic Republic Of
Phone 6721 0
+982188963122
Fax 6721 0
Email 6721 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.