Protocol summary
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Study aim
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Investigation of anti-inflammatory effect of strowell capsules on inflammatory factors in ischemic stroke patients
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Design
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Two arm parallel group randomized double-blind placebo-controlled trial
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Settings and conduct
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The trial is performed in Imam Hossein and Imam Khomeini Hospitals based on double-blind block randomization. All the people involved in the caregiving and treatment of the patients including companions, physicians, nurses and investigators are unbeknownst of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: The inclusion age should be in 40-80 years range; National Institute of Health Stroke Scale (NIHSS) range is 4-20; and that of Body mass index (BMI) is 20-25. Focal neurological signs are confirmed by the Magnetic Resonance Imaging (MRI).
Exclusion criteria: hemorrhagic stroke; history of Nonsteroidal Anti-inflammatory Drugs(NSAID) allergic response; history of gastrointestinal bleeding; kidney and liver failure; rheumatic and autoimmune diseases, myocardial infarction within previous 48 hours; previous stroke; pregnancy or lactation; malignancies; various other inflammatory diseases during the trial and those patients who have received tissue plasminogen activator (tPA).
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Intervention groups
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strowell capsules receiving group
Placebo group
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Main outcome variables
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"Stroke intensity"
"Blood Inflammatory markers"
General information
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Reason for update
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Due to publishing the results of the study under the brand name Strowell, title has been modified accordingly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170315033086N5
Registration date:
2019-05-05, 1398/02/15
Registration timing:
retrospective
Last update:
2021-06-13, 1400/03/23
Update count:
1
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Registration date
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2019-05-05, 1398/02/15
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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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2017-05-01, 1396/02/11
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Expected recruitment end date
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2018-08-02, 1397/05/11
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Actual recruitment start date
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2017-06-25, 1396/04/04
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Actual recruitment end date
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2018-12-01, 1397/09/10
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Trial completion date
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2019-02-20, 1397/12/01
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Scientific title
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Investigation of Anti-inflammatory Effects of strowell capsules on Plasma Inflammatory Factors in Ischemic Stroke Patients: A Randomized, Double-blind Placebo-controlled Trial
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Public title
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Circulatory Cytokine Profiles of Ischemic Stroke Patients after Treatment with strowell capsules
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis, based on neurological diagnostic signs and confirmed by Magnetic Resonance Imaging (MRI)
National Institutes of Health Stroke Scale (NIHSS) should be in 4 - 20 range at the time of admission.
Body mass index (BMI) should be in 20-25 range
No inflammatory diseases
Exclusion criteria:
Hemorrhagic stroke
transient ischemic attack (TIA)
History of gastrointestinal bleeding
History of sensitivity to NSIADs
Previous stroke
Myocardial infarction within the previous 48 hours
Kidney and liver failure
Immunosuppressive medications
Stroke patients who have received tissue plasminogen activator (tPA).
Rheumatoid and autoimmune diseases
Malignancies
Pregnancy or lactation
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Age
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From 40 years old to 80 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 analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
43
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the patient-assigned code and the order of recruitment is generated by an epidemiologist. Given the block size of 4, there are 6 possible ways to equally assign participants to each treatment group. Therefore recruitment of participants to each treatment category is randomized and unpredictable. Following this randomization, an equal number of participants is randomly assigned to each treatment 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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Patient allocation and sequencing are done blindly. All the members of the staff who are involved in performing the enrollment, physicians, nurses and the investigation team as well as patients and their guardians, are masked. The research group is uninformed of drug and/or placebo prescription and its dosage. Codes will be written on the sealed envelopes and the medication bottles. Following patient assessment by the doctor, according to the admission sequence, the envelopes with the same number will be opened. Subsequently, the patients are going to be handed a bottle that could be the drug or placebo based on the assigned code. Therefore, the patient is unbeknownst whether the intervention is strowell capsules or the placebo.
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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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2017-01-03, 1395/10/14
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Ethics committee reference number
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IR.SBMU.MSP.REC.1395.409
Health conditions studied
1
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Description of health condition studied
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Ischemic stroke
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ICD-10 code
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I63.9
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ICD-10 code description
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Cerebral infarction, unspecified
Primary outcomes
1
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Description
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Stroke intensity
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Timepoint
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At the commencement of the investigation and after taking the strowell capsules
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Method of measurement
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NIH Stroke Scale questionnaire for quantifying stroke severity (11 items are included, level of consciousness, horizontal eye movement, visual field test, facial palsy, motor arm and motor leg, limb ataxia, sensory, language, speech, extinction and inattention)
2
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Description
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Pro- and anti-inflammatory plasma markers
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Timepoint
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At the investigation commencement and after the intervention
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Method of measurement
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ELISA assay kit
Intervention groups
1
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Description
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Intervention group: strowell capsules receiving group, 1 month, 3 times/day, Oral Administration (800 mg)
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo group,1 month, 3 times/day, Oral (800 mg)
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Category
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Treatment - Drugs
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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Shahid Beheshti 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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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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collected de-identified IPD, IPD collected for the primary outcome measure only
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When the data will become available and for how long
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De-identified data will be available starting from April, 2021
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To whom data/document is available
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Academics employed at various research/university institutions and the industry.
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Under which criteria data/document could be used
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No specific condition are specified.
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From where data/document is obtainable
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Behnam Safarpour Lima, Shahid Madani St., Tehran, Iran,
Tel: +982173433000
Mob. 091229811576
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What processes are involved for a request to access data/document
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1- The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes.
2- Following the receipt of request letter, the data would be provided in no more than two weeks.
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Comments
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