Investigating the effect of boswellic acid on the clinical outcomes of patients with acute ischemic stroke
Design
An open-label clinical trial that will be conducted on 70 acute ischemic stroke patients. Patients will be assign to one of the intervention or control groups using the block randomization method, based on the generated-computer numbers by the random allocation software.
Settings and conduct
In this study, patients patients with acute ischemic stroke admitted to Urmia Imam Khomeini Hospital will be enrolled. Patients will be randomly divided into two groups. Patients in the intervention group, in addition to routine stroke treatments that include anti-ischemic drugs, will receive oral boswellic acid 360 mg tablets from Gol Daru every 6 hours for one month. Routine stroke treatments will be performed in the control group. The study will be done without blinding.
Participants/Inclusion and exclusion criteria
In this study, 70 patients with acute ischemic stroke in the age range of 18 to 80 years and having a score of 5-21 based on NIHSS will be included. Patients with reduced level of consciousness will not be included in the study.
Intervention groups
Patients in the intervention group, in addition to routine stroke treatments that include anti-ischemic drugs, will receive oral boswellic acid 360 mg tablets from Gol Daru every 6 hours for one month. Routine stroke treatments will be performed in the control group.
Main outcome variables
Function score based on NIHSS; Inflammatory factors; CBC cell count including (RBC, WBC, Hb)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059724N1
Registration date:2023-10-24, 1402/08/02
Registration timing:prospective
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Rezvan Norouzzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8003
Email address
norouzzadeh.r@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of boswellic acid on the clinical outcomes of patients with acute ischemic stroke
Public title
Investigating the effect of boswellic acid in acute ischemic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute ischemic stroke
Age between 18 and 80 years
Hospitalization on the first day of symptoms
A score between 5-21 before treatment based on the National Institutes of Health stroke scale (NIHSS)
Exclusion criteria:
Receiving alteplase or retplase in the hospital
NIHSS score above 21 and loss of consciousness
The presence of gastrointestinal complications that make it impossible to take drug.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the intervention or control groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization" will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups. Thus, the randomization process will continue until the final sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
NIHSS questionnaire
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
Laboratory kit based on the Westergren test
3
Description
C-reactive protein (CRP)
Timepoint
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
Laboratory kit based on agglutination test
4
Description
White blood cell count (WBC)
Timepoint
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
Cell counter
5
Description
Red blood cell count (RBC)
Timepoint
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
Cell counter
6
Description
Hemoglobin (Hb)
Timepoint
The first day of hospitalization (before the intervention) and one month after the intervention
Method of measurement
Cell counter
Secondary outcomes
1
Description
Complications
Timepoint
One month after the intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Patients in the intervention group, in addition to routine stroke treatments that include anti-ischemic drugs, will receive oral boswellic acid 360 mg tablets from Gol Daru every 6 hours for one month.
Category
Treatment - Drugs
2
Description
Control group: In the control group, routine stroke treatments including anti-ischemic drugs will be performed.