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Boswellia Serrata Extract Shows Cognitive Benefits in a Double-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial in Individuals Who Suffered Traumatic Brain Injury Publisher Pubmed



Meshkat S1, 2 ; Mahmoodi Baram S3, 4 ; Rajaei S3, 4 ; Mohammadian F2 ; Kouhestani E1 ; Amirzargar N5 ; Tafakhori A5 ; Shafiee S6 ; Meshkat M7 ; Balenci L8 ; Kiss A9 ; Riazi A8 ; Salimi A10 ; Aghamollaii V2 Show All Authors
Authors
  1. Meshkat S1, 2
  2. Mahmoodi Baram S3, 4
  3. Rajaei S3, 4
  4. Mohammadian F2
  5. Kouhestani E1
  6. Amirzargar N5
  7. Tafakhori A5
  8. Shafiee S6
  9. Meshkat M7
  10. Balenci L8
  11. Kiss A9
  12. Riazi A8
  13. Salimi A10
  14. Aghamollaii V2
  15. Salmani F3
  16. Karima S3
Show Affiliations
Authors Affiliations
  1. 1. School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Neurology, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  4. 4. Behbalin Co., Ltd, Incubation center for Pharmaceutical Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5. Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Department of Neurosurgery, Mazandaran University of Medical Sciences, Sari, Iran
  7. 7. School of Pharmacy, Azad University of Pharmaceutical Sciences, Tehran, Iran
  8. 8. Kondor Pharma Inc., 3403 American Drive, Toronto, ON, Canada
  9. 9. Department of Research Design and Biostatistics, Sunnybrook and Women’s College Health Sciences Center, Toronto, ON, Canada
  10. 10. School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Source: Brain Injury Published:2022


Abstract

Background: Traumatic brain injury (TBI) is a major cause of death and disability. TBI can result in neuropsychiatric and cognitive problems as well as neurodegenerative pathologies that can appear right after or develop and persist years after injury. Method: We conducted a double-blind, randomized, placebo-controlled clinical trial on patients who suffered from TBI three months to three years ago. The patients were randomized to placebo (n = 34) or K-Vie™ group (n = 46) for a treatment period of 3 months. The main primary outcomes include cognitive assessment in the Rey Auditory Verbal Learning Test-Recognition Test (RAVLT), Wechsler adult intelligence Digit Symbol Substitution Test (DSST) and trail-making test part B (TMT-B). Assessments were performed at baseline and at the month 3 follow-up visit. Linear mixed models were carried out to evaluate cognitive changes from baseline across all cognitive assessment tests. Result: The current study showed significant (p < 0.05) improvement in cognitive function of patients who were given K-Vie™ compared with placebo across the RAVLT, DSST and TMT-B performance assessments. A larger cohort would be beneficial to further confirm the clinical utility of K-Vie™ and assess its effects in acute phases of TBI. © 2022 Taylor & Francis Group, LLC.