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IRCT138804082093N1 IRCT 2009-11-30 Vice Chancellery for Research, Isfahan University of Medical Sciences Investigating the effect of Boswellia Serrata, a kind of herbal remedy on cognitive impairments following closed head injuries Investigating the effect of Boswellia Serrata supplementation on cognitive rehabilitation following diffuse axonal injuries 2009-11-30 anticipated 40 Complete https://irct.ir/trial/1718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment. 2 Diffuse axonal Injury. Intervention 1: Boswellia Serrata medical compound (400 mgr, three times daily, per oral, for 6 weeks. Intervention 2: Placebo(TDS,PO).
public Payam Moin
6th floor, No. 10, Sepehar building, Yahyakhan alley, Chaharbagh bala street
Isfahan Iran (Islamic Republic of) +98 31 1629 0630 payammoin@yahoo.com Isfahan University of Medical Sciences scientific Houshang Moin
6th floor, 10,Sepeh building, Yahyakhan alley,Chaharbagh bala street
Isfahan Iran (Islamic Republic of) +98 31 1629 0630 h_moin@med.mui.ac.ir Isfahan university of Medical Sciences Iran (Islamic Republic of) 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 15 years 65 years Both S06.2 Traumatic compression of brain NOS Treatment - Drugs Placebo Boswellia Serrata medical compound (400 mgr, three times daily, per oral, for 6 weeks Placebo(TDS,PO) Glasgow Outcome Scale Extended score. Timepoint: 2, 6 and 12 weeks after admission. Method of measurement: physical exam and history. Glasgow Coma Scale score. Timepoint: First day of admission, and 2, 6, and 12 weeks later. Method of measurement: Physical exam. Disability Rating Scale score. Timepoint: 2, 6 and 12 weeks after admission. Method of measurement: Physical exam and history. Mini-Mental State Examination score. Timepoint: 2, 6 and 12 weeks after admission. Method of measurement: Physical exam and history. Duration of admission. Timepoint: Number of days from admission to discharge. Method of measurement: follow up. Coma duration. Timepoint: from admission until Glasgow Outcome Scale score overgoes 9. Method of measurement: physical exam. Vice Chancellery for Research, Isfahan University of Medical Sciences Approved 2009-12-15 Isfahan University of Medical Sciences Daneshgah St., Isfahan, Iran Isfahan Iran (Islamic Republic of)