Protocol summary
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Study aim
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The effect of Curcuden on RRMS patients will be investigated
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Design
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We randomly divide 68 MS patients into intervention and control groups and we assign a code to each participant.
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Settings and conduct
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This study conduct in the Neurology Research Center of Tehran Imam Khomeini Hospital in double-blind manner. None of the patients are aware that in which group, control or intervention, they are. The doctor also prescribes the medicine as code A and B and no information is available n them about being placebo or medicine. The main neurologist of the project is the only one that is aware of this classification.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: RRMS patients who receive first-line treatment drugs for one year but have at least one relapse or active lesion. Meanwhile, at least one month away from the last attack of the disease and the patient's corticosteroid therapy. Patients should be between 18 to 60 years of age with EDSS between 0 and 5.5, and no Curcumin contraindications.
Exclusion criteria: Progressive MS patients or patients who have contraindication to use Curcumin or similar substances. The presence of any internal or systemic disease (such as anemia or liver conditions). Every patient is examined by MRI, general and inflammatory factors, once before and once after treatment
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Intervention groups
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The intervention group receive the medication for 6 months at a dose of 180 mg per day.
The control group receive placebo for a period of 6 months at a dose of 180 mg.
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Main outcome variables
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The amount of active lesions in the brain and spinal cord and the inflammatory factors of the blood will be compared before and after the treatment between the two groups of test and control.
In this way, the efficacy and non-toxicity of the drug will be investigated
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170128032241N2
Registration date:
2018-02-16, 1396/11/27
Registration timing:
registered_while_recruiting
Last update:
2019-08-20, 1398/05/29
Update count:
1
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Registration date
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2018-02-16, 1396/11/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Alborz Nanomed Tech Co. , Maryam Mohajeri
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Expected recruitment start date
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2017-10-23, 1396/08/01
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Expected recruitment end date
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2018-10-23, 1397/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of safety and efficacy of oral curcuden on remitting and relapsing multiple sclerosis patients (RRMS): clinical trial study of Phase A2
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Public title
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Effect of oral curcuden on multiple sclerosis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
RRMS patients who will receive first-line treatment drugs for one year
Have at least one relapse or active lesion
At least one month has passed since the last attack of the disease
At least one month ha passed from the patient's corticosteroids
Average age of 18 to 60 years
0 <EDSS <5.5
No curcumin contraindications
Exclusion criteria:
Progressive MS patients
Patients who have contraindicated curcumin or similar substances
The presence of any internal or systemic illness (such as anemia or liver problems)
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Use a random number table, we assign patients the code within the specified interval, then we classify the odd codes in the intervention group and the even codes in the control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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We mark drug with code A and placebo with the code B, only the analyst is aware of this codes, each group of patients receive A or B randomly, the physician and the patient are not aware of this codes.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Random Numbers Table
Ethics committees
1
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Ethics committee
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Approval date
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2019-07-29, 1398/05/07
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Ethics committee reference number
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IR.SBMU.REC.1398.054
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Demyelinating diseases of the central nervous system(Multiple sclerosis)
Primary outcomes
1
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Description
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Active lesions in the brain and spinal cord (plaque)
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Timepoint
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Before the intervention (month 0) and the sixth month after the intervention
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Method of measurement
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MRI
2
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Description
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Blood inflammatory factors
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Timepoint
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Before the intervention (month 0) and the sixth month after the intervention
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Method of measurement
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Blood Test
Secondary outcomes
1
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Description
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Clinical relapse within 6 months
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Timepoint
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Every 6 months
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Method of measurement
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MRI
2
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Description
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Effect of medication on other MRI parameters such as T2 lesions, new T2 lesions and brain atrophy
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Timepoint
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Every 6 months
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Method of measurement
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MRI
3
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Description
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Effect of medication on changes in inflammatory and anti-inflammatory mediators
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Timepoint
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Before intervention and 6 months after intervention
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Method of measurement
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Blood test
4
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Description
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Effect of medication on improving patient lifestyle
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Timepoint
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Before intervention and 6 months after intervention
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Method of measurement
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EDSS Criteria, Fatigue, Focus, Balance ...
Intervention groups
1
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Description
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Intervention group 1: 34 RRMS patients who received at least 6 months of first line treatment of MS (beta-interferon) but have clinically experienced at least one relapse during medication or an active lesion in their brain or spinal cord.
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Category
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Treatment - Drugs
2
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Description
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Control group: 34 RRMS patients who receive at least 6 months of first line treatment of MS (beta-interferon) but have clinically experienc at least one relapse during medication or an active lesion in their brain or spinal cord.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Alborz Nanomed Tech Co.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Clinical study report
In this report, the analysis of final information related to the main implications of the study will be published in scientific papers in international journals. No patient information or study has been published in this article.
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When the data will become available and for how long
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Start access from the date of publication of the study results
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To whom data/document is available
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This data will be applicable to anyone who has access to the full text of the scientific article, including researchers and other individuals.
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Under which criteria data/document could be used
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These documents can be used as research results and cited in other papers and scientific projects. Also, these results can be used to design future phases of clinical study.
Certainly, in the case of the registration of intellectual property, the right to use this data in the industry is the sole owner of the project.
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From where data/document is obtainable
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These data will be available in the published articles of this project. Obviously, after publication of the articles, the referral address and the link with the author of the article will be available to the applicant in the available scientific journal to receive the documentation.
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What processes are involved for a request to access data/document
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The documentation will be available to anyone who has access to the full text of the article. If additional information is requested from the applicant, the author will be responsible for posting the article and requesting the data, if agreed upon by the author and the owner. The required information plan will be available to the applicant in less than 1 month.
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Comments
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No more information