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Investigating the effect of Boswellia Serrata supplementation on cognitive rehabilitation following diffuse axonal injuries

Protocol summary

Summary
In a pilot, double blind, cross over clinical trial, we are going to assess the effect of boswellia serata extract on neurocognitive rehabilitation following closed head injuries. We, prospectively, recruit 40 patients admitted with initial diagnosis of diffuse axonal injury. The patients are assigned in two groups. One group will receive Boswellia serrata extract, 400mg, 3 times a day, while the other group will receive placebo for 6 weeks. Then, the patients will be crossed over alternative intervention for another 6 weeks period. Neuro-cognitive function tests including Disability Rating Scale (DRS), the Glasgow outcome Scale/Extended (GOSE), and the Mini-mental Status Test (MMSE) are applied 1-2 weeks, 6 weeks, and 12 weeks after beginning of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804082093N1
Registration date: 2009-11-30, 1388/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-11-30, 1388/09/09
Registrant information
Name
Payam Moin
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1629 0630
Email address
h_moin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2009-11-30, 1388/09/09
Expected recruitment end date
2010-09-01, 1389/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Boswellia Serrata supplementation on cognitive rehabilitation following diffuse axonal injuries
Public title
Investigating the effect of Boswellia Serrata, a kind of herbal remedy on cognitive impairments following closed head injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15 – 55 years old, stable Vital signs, Glasgow Coma Scale score of 12 or less within the first 24 hours of injury, Post traumatic amnesia of at least 24 hours, loss of consciousness immediately after motor vehicle crash, subjects with no known life-threatening or unstable dangerous disease before head injury, ability to receive medication orally or by nasogastric tube, no active severe infection Exclusion criteria: pregnancy breast feeding, Multiple traumas that may impair the accuracy of results, penetrating head injury, receiving chronic asthmatic, anticancer, antifungal, anti-inflammatory pain relievers, immunomodulators, or sedatives, Prior significant TBI, brain tumor, cerebral vascular event, other stable brain insults, Prior history or familial history of any severe allergic or atopic disease, The presence of any severe or progressive lesion such as intracranial hematoma that would lead to open cranial surgery after injury, Any acute disturbance in vital signs or laboratory data being or not being attributable to boswellia extract, or any cutaneous or other organ lesions which may imply allergic reaction, history of severe psychological disorder in which cognitive functions are impaired like mental retardation or dementia, Patients undergone brain surgery after or before trauma, Refractory and severe vomiting, past history or labratory data suggesting liver or renal disease
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Daneshgah St., Isfahan, Iran
City
Isfahan
Postal code
Approval date
2009-12-15, 1388/09/24
Ethics committee reference number
288262

Health conditions studied

1

Description of health condition studied
Diffuse axonal Injury
ICD-10 code
S06.2
ICD-10 code description
Traumatic compression of brain NOS

Primary outcomes

1

Description
Glasgow Outcome Scale Extended score
Timepoint
2, 6 and 12 weeks after admission
Method of measurement
physical exam and history

2

Description
Glasgow Coma Scale score
Timepoint
First day of admission, and 2, 6, and 12 weeks later
Method of measurement
Physical exam

3

Description
Disability Rating Scale score
Timepoint
2, 6 and 12 weeks after admission
Method of measurement
Physical exam and history

4

Description
Mini-Mental State Examination score
Timepoint
2, 6 and 12 weeks after admission
Method of measurement
Physical exam and history

Secondary outcomes

1

Description
Duration of admission
Timepoint
Number of days from admission to discharge
Method of measurement
follow up

2

Description
Coma duration
Timepoint
from admission until Glasgow Outcome Scale score overgoes 9
Method of measurement
physical exam

Intervention groups

1

Description
Boswellia Serrata medical compound (400 mgr, three times daily, per oral, for 6 weeks
Category
Treatment - Drugs

2

Description
Placebo(TDS,PO)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra and Kashani hospitals
Full name of responsible person
Street address
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research, Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi, MD
Street address
Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Payam Moin
Position
Medical student
Other areas of specialty/work
Street address
6th floor, No. 10, Sepehar building, Yahyakhan alley, Chaharbagh bala street
City
Isfahan
Postal code
Phone
+98 31 1629 0630
Fax
+98 31 1629 0630
Email
payammoin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Houshang Moin
Position
Full Professor
Other areas of specialty/work
Street address
6th floor, 10,Sepeh building, Yahyakhan alley,Chaharbagh bala street
City
Isfahan
Postal code
Phone
+98 31 1629 0630
Fax
+98 31 1629 0630
Email
h_moin@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Payam Moin
Position
Internship (medical student)
Other areas of specialty/work
Street address
6th floor, Sepehr residential complex, Yahyakhan alley, Chaharbagh bala St., Esfahan, Iran
City
Esfahan
Postal code
Phone
+98 31 1629 0630
Fax
Email
payammoin@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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