Boswellia serrata extract shows cognitive benefits in a double-blind, randomized, placebo-controlled pilot clinical trial in individuals who suffered traumatic brain injury

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.

KEYWORDS:

• Traumatic brain injury
• TBI
• boswellia serrata
• cognitive function
• anti-inflammatory
• cognition
• Clinical trial
• Boswellic acids

Acknowledgments

The authors thank all the patients with TBI and their caregivers for participating in the study.

Disclosure statement

The study was funded by Kondor Pharma Inc, Canada, who manufacture the Boswellia serrata supplement. The study was designed and conducted independently by the research team. The authors declare no financial or other conflicts of interest.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website

Ethical code and Clinical Trial Registration

All procedures were approved and supervised by the Tehran University of Medical Sciences (TUMS) ethics committee (Reference number: IR.TUMS.MEDICINE.REC.1397.526). The study was registered in the Iranian Registry of Clinical Trials (IRCT), a registry that is part of the WHO network https://www.who.int/clinical-trials-registry-platform/network/primary-registries/iranian-registry-of-clinical-trials-(irct) with identifier: IRCT20170315033086N5 (http://www.irct.ir/trial/47581).

Additional information

Funding

This project was supported by the Kondor Pharma Inc, Canada.