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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Protocol summary
Investigation of effect of Boswellia resin extract on the cognitive disorders of patients with traumatic brain injury
Investigation of effect of Inflawell capsules containing Boswellic acids on the cognitive disorders of patients with traumatic brain injury
Investigation of effect of Boswellia resin extractInflawell capsules containing Boswellic acids on the cognitive disorders of patients with traumatic brain injury
تعیین اثر عصاره صمغ کندر بر اختلالات شناختی بیماران آسیب مغزی تروماتیک
تعیین اثر کپسول اینفلاول حاوی اسیدهای بوسولیک بر اختلالات شناختی بیماران آسیب مغزی تروماتیک
تعیین اثر عصاره صمغ کندرکپسول اینفلاول حاوی اسیدهای بوسولیک بر اختلالات شناختی بیماران آسیب مغزی تروماتیک
گروه دریافت کننده عصاره صمغ کندر , گروه دریافت کننده پلاسبو
گروه دریافت کننده کپسول اینفلاول, گروه دریافت کننده پلاسبو
گروه دریافت کننده عصاره صمغ کندر کپسول اینفلاول, گروه دریافت کننده پلاسبو
General information
Enter all items in the exclusion criteria
Correct follow-up period
Correction of the details of intervention and running title
Enter all items inCorrection of the exclusion criteria Correct follow-up perioddetails of intervention and running title
وارد کردن تمام آیتم ها در معیارهای اکسکلوژن
تصحیح مدت زمان پایش
تصحیح و اضافه نمودن نام و جزییات مداخله و اصلاح عنوان
وارد کردن تمام آیتم ها در معیارهای اکسکلوژن تصحیح مدت زمان پایشو اضافه نمودن نام و جزییات مداخله و اصلاح عنوان
The efficacy of Boswellia resin extract in patients with cognitive impairment due to traumatic brain injury
The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury
The efficacy of Boswellia resin extractInflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury
بررسی اثر بخشی عصاره آلی بوسولیا در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک
بررسی اثر بخشی کپسول اینفلاول حاوی اسیدهای بوسولیک در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک
بررسی اثر بخشی عصاره آلی بوسولیاکپسول اینفلاول حاوی اسیدهای بوسولیک در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک
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
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
The efficacy of Boswellia resin extract compared to placeboInflawell capsules containing Boswellic acids 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
بررسی اثر بخشی عصاره آلی بوسولیا در مقایسه با گروه دارونما در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک بعد از فاز حاد، در بیماران ارجاع شده به درمانگاه نورولوژی بیمارستان روزبه در سال 97 و 98، کارآزمایی بالینی تصادفی دو سو کور
بررسی اثر بخشی کپسول اینفلاول حاوی اسیدهای بوسولیک در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک: کارآزمایی بالینی تصادفی دو سو کور، کنترل شده با دارونما
بررسی اثر بخشی عصاره آلی بوسولیا در مقایسه با گروه دارونماکپسول اینفلاول حاوی اسیدهای بوسولیک در بهبود اختلالات شناختی بیماران با آسیب مغزی تروماتیک بعد از فاز حاد، در بیماران ارجاع شده به درمانگاه نورولوژی بیمارستان روزبه در سال 97 و 98،: کارآزمایی بالینی تصادفی دو سو کور، کنترل شده با دارونما
Primary outcomes
#1
At the commencement of the investigation and after taking the Boswellia resin extract
At the commencement of the investigation and after taking Inflawell capsules
At the commencement of the investigation and after taking the Boswellia resin extractInflawell capsules
ابتدای مطالعه و پس از مصرف عصاره صمغ کندر
ابتدای مطالعه و پس از مصرف کپسول اینفلاول
ابتدای مطالعه و پس از مصرف عصاره صمغ کندرکپسول اینفلاول
Intervention groups
#1
Intervention group: Boswellia Resin extract receiving group, 3 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
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
Intervention group: Boswellia Resin extractInflawell receiving group, 3 month, 3 times/day, Oral Administration (400 mg), Frankincense extractBoswellic acids powder in OswehKondorPharma Pharmaceutical FactoryCompany (Canada), Iran was encapsulated in orange gelatin capsules (400 mg / capsule) and they were packed in brown container
گروه مداخله:گروه دریافت کننده عصاره صمغ کندر، به مدت سه ماه، سه بار در روز، خوراکی (400 میلی گرم)، پودر عصاره کندر در کارخانه داروسازی اسوه (ایران) در کپسولهای نارنجی ژلاتینی (400میلیگرم/کپسول) کپسوله و در قوطیهای کدر قهوه ای رنگ بسته بندی شدند
گروه مداخله:گروه دریافت کننده کپسول اینفلاول به مدت سه ماه، سه بار در روز، خوراکی (400 میلی گرم)، پودر اسیدهای بوسولیک در کارخانه داروسازی کندرفارما (کانادا) در کپسولهای نارنجی ژلاتینی (400میلیگرم/کپسول) کپسوله و در قوطیهای کدر قهوه ای رنگ بسته بندی شدند
گروه مداخله:گروه دریافت کننده عصاره صمغ کندر،کپسول اینفلاول به مدت سه ماه، سه بار در روز، خوراکی (400 میلی گرم)، پودر عصاره کندراسیدهای بوسولیک در کارخانه داروسازی اسوهکندرفارما (ایرانکانادا) در کپسولهای نارنجی ژلاتینی (400میلیگرم/کپسول) کپسوله و در قوطیهای کدر قهوه ای رنگ بسته بندی شدند
Protocol summary
Study aim
Investigation of effect of Inflawell capsules containing Boswellic acids 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
Intervention groups
Inflawell capsules receiving group, Placebo gruop
Main outcome variables
Cognitive impairment intensity
General information
Reason for update
Correction of the details of intervention and running title
Acronym
IRCT registration information
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
Registration date
2020-07-19, 1399/04/29
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
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 Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury: A Randomized, Double-blind Placebo-controlled Trial
Public title
The efficacy of Inflawell capsules containing Boswellic acids 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 (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
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:
80
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 Inflawell capsules
Method of measurement
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)
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
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.