1.Determining the frequency of cognitive disorders in the study population in the group of Crocin and Placebo 2.Comparison of changes in cognitive impairment before and after drug administration between Placebo and Crocin 3.Determining the frequency of depression and anxiety in the study population in the group of Crocin and Placebo 4.Comparison of changes in depression and anxiety before and after drug administration between Placebo and Crocin
Design
Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 50 patients, phase 2
Settings and conduct
Population and sample size: 50 eligible multiple sclerosis patients and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. Time of intervention: 8 weeks.
Participants/Inclusion and exclusion criteria
Entry requirements; Age between 18 and 55 years; Testable measurable cognitive impairment McFims attributed to multiple sclerosis;Testable Measurable mental health impairment including anxiety and depression (Beck) attributed to Multiple Sclerosis; Diagnosis of multiple sclerosis based on McDonald's criteria. No entry conditions; sensitivity to crocin products; Clinical relapse of Multiple Sclerosis with in 30 days of screening
Intervention groups
Group A will be treated with Crocin and group B will be treated with Placebo
Main outcome variables
Language; executive function; processing speed ; functional memory; new learning power ; depression ; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220221054087N1
Registration date:2022-03-09, 1400/12/18
Registration timing:prospective
Last update:2022-03-09, 1400/12/18
Update count:0
Registration date
2022-03-09, 1400/12/18
Registrant information
Name
Bahador Rezapoor kafteroodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 3780
Email address
rezapoor-b@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-08, 1401/01/19
Expected recruitment end date
2022-05-09, 1401/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of Crocin on Cognitive impairment, mental health,Oxidative Stress and inflammatory factors in Multiple Sclerosis patients
Public title
Investigate the effect of Crocin in Multiple Sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Multiple Sclerosis based on McDonald's criteria Age between 18 to 55 years
Testable Measurable Cognitive impairment (MACFIMS) attributed to Multiple Sclerosis
Testable Measurable mental health impairment including anxiety and depression (Beck) attributed to Multiple Sclerosis
Exclusion criteria:
Pregnancy
Breast feeding
History of Diabetes, heart failure, renal failure ,hepatic failure and psychological disorder
History of substance addiction
Sensitivity to crocin products
Clinical relapse of Multiple Sclerosis with in 30 days of screening
Changes in the treatment of Multiple Sclerosis within 30 days of screening
Existence of any underlying factor and disease that causes dementia and cognitive impairment
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2022-02-19, 1400/11/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.204
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
Cognitive Disorder Score in MacFims Questionnaire
Timepoint
Perform MacFims test at the beginning of the study and 8 weeks after of the study
Method of measurement
MacFims Questionnaire
2
Description
Accompanying depression score
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Beck's Depression Inventory
3
Description
Accompanying anxiety score
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Beck's anxiety Inventory
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Total glutathione
Timepoint
At the beginning of the study and after 8weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Hs-CRP
Timepoint
At the beginning of the study and after 8weeks of intervention
Method of measurement
Elisa kit
Intervention groups
1
Description
Intervention group: In this group of patients (n=25) will be requested to take two crocin tablets daily for 8 weeks (each tablet contain 15 mg crocin). The crocin tablets will be produced in the pharmacy faculty of Mashhad University of Medical Sciences from saffron.
Category
Treatment - Drugs
2
Description
Control group: In this group of patients (n=25) will be requested to take two placebo tablets daily for 8 weeks. The placebo tablets (Contain Avicel) will be produced in the pharmacy faculty of Mashhad University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Clinic (Shahid Beheshti hospital)
Full name of responsible person
Ebrahim Kouchaki Nasrabadi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0026
Email
koochaki_2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0026
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Bahador Rezapoor Kafteroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0026
Email
Bahador.rezapoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Bahador Rezapoor Kafteroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0026
Email
Bahador.rezapoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Bahador Rezapoor Kafteroodi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0026
Email
Bahador.rezapoor@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Dr. Bahador Rezapoor Kafteroodi is committed to presenting all the achievements of the project in accordance with the framework of the National Institute for Medical Research Development in the Islamic Republic of Iran.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available