Protocol summary
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Study aim
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Investigation of effect of Inflawell capsules containing Boswellic acids on the cognitive disorders of patients with traumatic brain injury
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Design
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Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Inflawell capsules receiving group, Placebo gruop
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Main outcome variables
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Cognitive impairment intensity
General information
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Reason for update
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Correction of the details of intervention and running title
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170315033086N6
Registration date:
2020-07-19, 1399/04/29
Registration timing:
retrospective
Last update:
2021-03-17, 1399/12/27
Update count:
2
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Registration date
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2020-07-19, 1399/04/29
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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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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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2019-01-10, 1397/10/20
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Actual recruitment end date
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2020-02-20, 1398/12/01
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Trial completion date
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2020-04-20, 1399/02/01
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Scientific title
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The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury: A Randomized, Double-blind Placebo-controlled Trial
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Public title
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The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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 (such as Phenytoin, Topiramate, Levetiracetam)
Epidural hematoma, subdural hematoma and Contusion
substance abuse
Previous brain trauma
Multiple sclerosis, Bipolar mood disorder, Schizophrenia, aphasia, spinal cord injury, motor disorder
Lactation and pregnanacy
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Age
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No age limit
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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
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Sample size
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Target sample size:
100
Actual sample size reached:
80
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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 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.
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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 drug 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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2018-11-10, 1397/08/19
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.526
Health conditions studied
1
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Description of health condition studied
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Traumatic brain injury
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ICD-10 code
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S06.2
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ICD-10 code description
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Diffuse traumatic brain injury
Primary outcomes
1
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Description
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Cognitive impairment intensity
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Timepoint
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At the commencement of the investigation and after taking Inflawell capsules
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Method of measurement
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Rey Auditory Verbal Learning Test-Recognition Test (AVLT-R), Wechsler adult intelligence Digit Symbol Substitution Test (DSST) and trail-making test part B (TMT-B)
Intervention groups
1
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Description
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Intervention group: Inflawell receiving group, 3 month, 3 times/day, Oral Administration (400 mg), Boswellic acids powder in KondorPharma Pharmaceutical Company (Canada), was encapsulated in orange gelatin capsules (400 mg / capsule) and they were packed in brown container
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo receiving group, 3 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
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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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Vice-Chancellor of Research Affairs, Tehran university of medical sciences
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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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No
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Title of funding source
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Vice-Chancellor of Research Affairs, Tehran university of medical sciences, Tehran 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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No - There is not 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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Undecided - It is not yet known if there will be a plan to make this available
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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 deidentified 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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Deidentified data will be available starting from April, 2022
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To whom data/document is available
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People working in academic institutions or people working in businesses.
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Under which criteria data/document could be used
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No specific condition
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From where data/document is obtainable
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Vajihe Aghamolaie, Roozbeh hospital, Tehran University of Medical Sciences, Tel: 00982155419151, Mobile phone:00989133412204
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What processes are involved for a request to access data/document
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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.
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Comments
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