Investigation of Anti-inflammatory Effects of Boswellia Resin Extract on Plasma Inflammatory Factors in Ischemic Stroke Patients: A Randomized, Double-blind Placebo-controlled Trial
Investigation of anti-inflammatory effect of Boswellia resin extract on inflammatory factors in ischemic stroke patients
Design
Two arm parallel group randomized double-blind placebo-controlled trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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).
Intervention groups
Boswellia resin extract receiving group
Placebo group
Main outcome variables
"Stroke intensity"
"Blood Inflammatory markers"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033086N5
Registration date:2019-05-05, 1398/02/15
Registration timing:retrospective
Last update:2019-05-05, 1398/02/15
Update count:1
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Saeed Karima
Name of organization / entity
Shahid Beheshti University of Medical Sciences (SBMU)
Country
Iran (Islamic Republic of)
Phone
+98 21 9666 1028
Email address
karima@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2018-08-02, 1397/05/11
Actual recruitment start date
2017-06-25, 1396/04/04
Actual recruitment end date
2018-12-01, 1397/09/10
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Investigation of Anti-inflammatory Effects of Boswellia Resin Extract on Plasma Inflammatory Factors in Ischemic Stroke Patients: A Randomized, Double-blind Placebo-controlled Trial
Public title
Circulatory Cytokine Profiles of Ischemic Stroke Patients after Treatment with Boswellia Resin Extract
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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 Boswellia resin extract or the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences, School of Medicine
At the commencement of the investigation and after taking the Boswellia resin extract
Method of measurement
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
Description
Pro- and anti-inflammatory plasma markers
Timepoint
At the investigation commencement and after the intervention
What processes are involved for a request to access data/document
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.