Protocol summary
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Study aim
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Determining the effect of hydroalcoholic extracts of Flaxseed and Nigella Sativa plants on fatigue in MS patients
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Design
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A double-blind randomized clinical trial with two groups: Flaxseed, Nigella Sativa, and placebo
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Settings and conduct
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The study will be conducted at Imam Reza Hospital. Patients will be randomly divided into two groups of Flaxseed, Nigella Sativa, and placebo by block method. The study is a double-blind (researchers and participants will not be aware of the groups involved).
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Participants/Inclusion and exclusion criteria
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Having stable condition for at least 8 weeks before entering the study, The score and assessment of fatigue of the people included in the study by the tests should be higher than the minimum standards, The psychotropic treatment regimens that the patients had before the start of the study should be adjusted for at least 4 weeks before the start of the study, The patient has not had a relapse attack in the last 4 months, The patient has not had an active infection in the last 4 months, The patient has not received a corticosteroid pulse in the last 4 months, History of suicide attempts or suicidal thoughts
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Intervention groups
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The Flaxseed and Nigella Sativa group will receive a soft gel containing 0.75 ml of each plant every 12 hours for three months. The control group will receive a 1.5 ml soft gel containing additives.
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Main outcome variables
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The level of fatigue that using the questionnaire before starting the drug and three months later (after taking the drug completely)
General information
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Reason for update
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The English names of plants are written incorrectly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140617018126N6
Registration date:
2022-11-01, 1401/08/10
Registration timing:
retrospective
Last update:
2024-11-02, 1403/08/12
Update count:
1
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Registration date
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2022-11-01, 1401/08/10
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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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Expected recruitment start date
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2021-11-22, 1400/09/01
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Expected recruitment end date
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2022-03-19, 1400/12/28
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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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The effect of hydroalcoholic extracts of Flaxseed (seed of Linum usitatissimum) and Nigella Sativa plants on fatigue in MS patients
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Public title
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The effect of Flaxseed and Nigella Sativa on MS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with MS who had a stable condition for at least 8 weeks before entering the study
The score and assessment of fatigue of the people included in the study by the tests should be higher than the minimum standards
The psychotropic treatment regimens that the patients had before the start of the study should be adjusted for at least 4 weeks before the start of the study.
Exclusion criteria:
The patient has not had a relapse attack in the last 4 months
The patient has not had an active infection in the last 4 months
The patient has not received a corticosteroid pulse in the last 4 months.
History of suicide attempts or suicidal thoughts
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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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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples will be randomly assigned to six blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Flaxseed and Nigella Sativa, and Placebo. Then based on blocks and allocation sequences, each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 50 are written (in order of allocation sequence). The pockets will contain white boxes containing Flaxseed, Nigella Sativa, or Placebo soft gels. Only the person in charge of packing drugs will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine each person receives. The first person will be given pocket number 1, which will continue until completion. soft gels will be similar in shape, size, color, and, smell.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 50 are written (in order of allocation sequence). The pockets will contain white boxes containing Flaxseed and Nigella Sativa, or Placebo capsules. Only the person in charge of packing soft gels will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine each person receives. The first person will be given pocket number 1, which will continue until completion. All soft gels will be similar in shape, size, color, and smell.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-10, 1401/07/18
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Ethics committee reference number
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IR.TBZMED.REC.1401.657
Health conditions studied
1
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Description of health condition studied
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Fatigue of MS patients
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Fatigue in MS patients
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Timepoint
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MFIS questionnaire before taking and three months after taking drugs
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: This group will receive a capsule containing 0.75 ml Flaxseed and 0.75 ml Nigella Sativa soft gels every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company.
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Category
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Treatment - Drugs
2
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Description
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Control group: This group will receive a softgel containing 1.5 ml of additives every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat.
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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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Tabriz University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not 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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No - There is not 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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No - There is not a plan to make this available