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Investigating the effect of Boswellia Serrata, a kind of herbal remedy on cognitive impairments following closed head injuries

Phase 2
Conditions
Traumatic compression of brain NOS
Diffuse axonal Injury.
Registration Number
IRCT138804082093N1
Lead Sponsor
Vice Chancellery for Research, Isfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
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

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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