The efficacy of Boswellia resin extract compared to placebo in patients with cognitive impairment due to traumatic brain injury referred to neurology clinic of Roozbeh Hospital in 2018-2019: A Randomized, Double-blind Placebo-controlled Trial
Investigation of effect of Boswellia resin extract on the cognitive disorders of patients with traumatic brain injury
Design
Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Trial will be performed in Roozbeh hospital based on block randomization in double blind manner. Every person who is involved in caring and treatment of patients including proxies, physicians and nurses are masked and investigators are all masked also
Participants/Inclusion and exclusion criteria
Inclusion criteria: traumatic brain injury patients
Patients who are in 3 months to 3 years from the time of traumatic brain injury
Exclusion criteria: Patients with uncontrollable seizures
Patients with impaired level of consciousness
Patients with (Glasgo outcome scale) GOS less than 3
Taking anticholinergic drugs
Taking anticonvulsants and sedatives drugs
Epidural hematoma, subdural hematoma and Contusion
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
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2019-01-10, 1397/10/20
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-04-20, 1399/02/01
Scientific title
The efficacy of Boswellia resin extract compared to placebo in patients with cognitive impairment due to traumatic brain injury referred to neurology clinic of Roozbeh Hospital in 2018-2019: A Randomized, Double-blind Placebo-controlled Trial
Public title
The efficacy of Boswellia resin extract in patients with cognitive impairment due to traumatic brain injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
traumatic brain injury patients
Patients who are in 3 months to 3 years from the time of traumatic brain injury
Exclusion criteria:
Patients with uncontrollable seizures
Patients with impaired level of consciousness
Patients with (Glasgo outcome scale) GOS less than 3
Taking anticholinergic drugs
Taking anticonvulsants and sedatives drugs
Epidural hematoma, subdural hematoma and Contusion
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
81
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 via Stata v.15 software. 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 drug 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 Tehran University of Medical Sciences, School of Medicine
Street address
No 1, Poursina St., Ghods St., Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.526
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Cognitive impairment intensity
Timepoint
At the commencement of the investigation and after taking the Boswellia resin extract
Method of measurement
Trail making test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Boswellia Resin extract receiving group, 1 month, 3 times/day, Oral Administration (400 mg), Frankincense extract powder in Osweh Pharmaceutical Factory, Iran was encapsulated in orange gelatin capsules (400 mg / capsule) and they were packed in brown container
Category
Treatment - Drugs
2
Description
Control group: placebo receiving group, 1 month, 3 times/day, oral administration, Microcrystalline cellulose compound was also purchased under the brand name AVICEL (particle diameter: less than 50 micrometers) as placebo from Exir Pharmaceutical Company, Iran and encapsulated in Osweh Pharmaceutical Factory in orange gelatin capsules similar to the drug group (400 mg / capsule) and they were packed in brown container
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Vajiheh Aghamolaie
Street address
after Lashgar Crossroads, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vajiheh Aghamolaie
Street address
After Lashgar crossroads, South Karegar Street
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Grant name
Vice-Chancellor of Research Affairs, Tehran university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor of Research Affairs, Tehran university of medical sciences, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vajihe Aghamolie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
After Lashgar crossroads, South Karegar Street
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vajihe Aghamolaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
After Lashgar crossroads, South Karegar St.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vajihe Aghmolaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
After Lashgar crossroads, South Karegar St.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
collected deidentified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
Deidentified data will be available starting from April, 2022
To whom data/document is available
People working in academic institutions or people working in businesses.
Under which criteria data/document could be used
No specific condition
From where data/document is obtainable
Vajihe Aghamolaie, Roozbeh hospital, Tehran University of Medical Sciences, Tel: 00982155419151, Mobile phone:00989133412204
What processes are involved for a request to access data/document
The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in one month.