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Efficacy of inflawell capsules containing Boswellic acids on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia

Protocol summary

Study aim
Efficacy of inflawell capsules containing Boswellic acids on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia
Design
Single center Clinical trial with a single assignment group, phase 2 on 20 patients
Settings and conduct
Trial will be performed in Roozbeh hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: behavioral and language variant of Frontotemporal dementia based on guidelines: Rascovsky K, Hodges JR, Knopman D, et al. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011;134; Gorno‐Tempini ML, Hillis AE, Weintraub S, et al. Classification of primary progressive aphasia and its variants. Neurology. 2011;76:1006‐1014. Exclusion criteria: other specific diseases of the central nervous system such as Parkinson's, multifactorial dementia, anterior brain dementia, Huntington's disease, hydrocephalus, brain tumors confirmed by MRI, severe paralysis of the nerve of the supernuclear body, epilepsy, clots between layers of brain tissue, multiple sclerosis and other dementias; taking NSAIDs and systemic corticosteroids for previous two months continuously; severe cardiovascular disease, kidney and liver disorders; psychiatric disorders include bipolar disorder and schizophrenia under medication; drugs or alcohol abuse; brain-related surgical interventions; head trauma and progressive degenerative motor disorder; metabolic and systemic diseases.
Intervention groups
Inflawell receiving group, 3 month, 3 times/day, Oral Administration (400 mg), Inflawell capsules containing Boswellic acids has been provided by KondorPharma company (Canada) in orange gelatin capsules (400 mg / capsule) and were packed in brown containers.
Main outcome variables
Cognitive and behavioral symptom changes; DTI (Diffusion tensor imaging ) MRI changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170315033086N8
Registration date: 2021-01-06, 1399/10/17
Registration timing: retrospective

Last update: 2021-01-06, 1399/10/17
Update count: 0
Registration date
2021-01-06, 1399/10/17
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
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of inflawell capsules containing Boswellic acids on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia
Public title
Efficacy of inflawell capsules on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Behavioral variant of Frontotemporal dementia based on guideline: Rascovsky K, Hodges JR, Knopman D, et al. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011;134 Language variant of Frontotemporal dementia based on guideline: Gorno‐Tempini ML, Hillis AE, Weintraub S, et al. Classification of primary progressive aphasia and its variants. Neurology. 2011;76:1006‐1014
Exclusion criteria:
Other specific diseases of the central nervous system such as Parkinson's, multifactorial dementia, anterior brain dementia, Huntington's disease, hydrocephalus, brain tumors confirmed by MRI, severe paralysis of the nerve of the supernuclear body, epilepsy, clots between layers of brain tissue, multiple sclerosis and other dementias Taking NSAIDs and systemic corticosteroids for previous two months continuously Severe cardiovascular disease, kidney and liver disorders Psychiatric disorders include bipolar disorder and schizophrenia under medication Drugs or alcohol abuse Brain-related surgical interventions head trauma and progressive degenerative motor disorder Metabolic and systemic diseases
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2019-05-25, 1398/03/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.146

Health conditions studied

1

Description of health condition studied
Frontotemporal dementia
ICD-10 code
G31.0
ICD-10 code description
Frontotemporal dementia

Primary outcomes

1

Description
Changes in the lesion area of brain
Timepoint
At the commencement of the investigation and 3 months after taking inflawell
Method of measurement
MRI ( Diffusion Tensor Imaging)

Secondary outcomes

1

Description
Changes in cognitive and behavioral symptoms
Timepoint
At the commencement of the investigation and 3 months after taking inflawell
Method of measurement
Clinical cognitive tests: Behavioral inventory and FTD-Clinical dementia rating (FTD-CDR), Neuropsychiatry inventory (NPI), Frontal assessment buttery (FAB), Persian naming test (PNT)

Intervention groups

1

Description
Intervention group: inflawell receiving group, 3 month, 3 times/day, oral administration (400 mg), inflawell containing Boswellic acids powders was manufactured in KondorPharma pharmaceutical Company (Canada), in orange gelatin capsules (400 mg / capsule) and were packed in brown containers.
Category
Treatment - Drugs

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central university building, Qods St., Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
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?
Yes
Title of funding source
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
Associated 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, 2024
To whom data/document is available
People working in academic institutions or people working in businesse
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,
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.
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