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

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2009
INTERVENTION: Boswellia Serrata medical compound (400 mgr, three times daily, per oral, for 6 weeks Intervention 1: Boswellia Serrata medical compound (400 mgr, three times daily, per oral, for 6 weeks. Intervention 2: Placebo(TDS,PO). Placebo Placebo(TDS,PO) Treatment ‐ Drugs CONDITION: Diffuse axonal Injury. ; Traumatic compression of brain NOS Traumatic compression of brain NOS PRIMARY OUTCOME: Disability Rating Scale 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. Glasgow Outcome Scale Extended 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. SECONDARY OUTCOME: Coma duration. Timepoint: from admission until Glasgow Outcome Scale score overgoes 9. Method of measurement: physical exam. Duration of admission. Timepoint: Number of days from admission to discharge. Method of measurement: follow up. INCLUSION 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 ac
Epistemonikos ID: 4988274875332f30bf8b2a8ea4062b1e13aebe2f
First added on: Aug 22, 2024