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Brain Sci. 2020 Jan 21;10(2). pii: E60. doi: 10.3390/brainsci10020060.

Clinical Outcomes of MLC601 (NeuroAiDTM) in Traumatic Brain Injury: A Pilot Study.

Author information

1
Department of Neurosurgery, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo General Academic Hospital, Surabaya Neuroscience Institute, Surabaya 60286, Indonesia.
2
Department of Neurosurgery, Dr. Kariadi Hospital Medical Center, Faculty of Medicine, Diponegoro University, 50111 Semarang, Indonesia.
3
Department of Biostatistics and Population Studies, Faculty of Public Health, Universitas Airlangga, 60111 Surabaya, Indonesia.

Abstract

BACKGROUND:

MLC601 is a natural product formulation from Chinese medicine that is extensively studied in ischemic stroke. Traumatic brain injury (TBI) shares pathophysiological mechanisms with ischemic stroke, yet there are few studies on the use of MLC601 in treating TBI. This Indonesian pilot study aimed to investigate clinical outcomes of MLC601 for TBI.

METHODS:

This randomized controlled trial included subjects with nonsurgical moderate TBI allocated into two groups: with and without MLC601 over three months in addition to standard TBI treatment. Clinical outcomes were measured by the Glasgow Outcome Scale (GOS) and Barthel Index (BI) observed upon discharge and at months (M) 3 and 6.

RESULTS:

Thirty-two subjects were included. The MLC601 group (n = 16) had higher GOS than the control group (n = 16) at all observation timepoints, though these differences were not statistically significant (p = 0.151). The BI values indicated a significant improvement for the MLC601 group compared to the control group at M3 (47.5 vs. 35.0; p = 0.014) and at M6 (67.5 vs. 57.5; p = 0.055). No adverse effects were associated with MLC601 treatment.

CONCLUSION:

In this cohort of nonsurgical moderate TBI subjects, MLC601 showed potential for a positive effect on clinical outcome with no adverse effects.

KEYWORDS:

MLC601; clinical outcome; nonsurgical lesion; traumatic brain injury

Conflict of interest statement

The study was designed and conducted independently by the research team. The authors declare no financial or other conflicts of interest. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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