Work

Effects of Kuanxiong aerosol for preventing acute mountain sickness: an exploratory small-sample randomized, placebo-controlled trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Background This study aimed to evaluate the potential efficacy and neurophysiological effects of Kuanxiong Aerosol (KXA) in preventing acute mountain sickness (AMS) during simulated high-altitude exposure. Methods In this randomized, double-blind, placebo-controlled trial, 20 healthy volunteers underwent a 6-hour hypobaric hypoxia session (simulated 4000 m) after receiving either KXA or placebo. Outcomes included the Lake Louise Score (LLS), AMS incidence, physiological parameters (SpO 2 , heart rate), cognitive performance (PMT, Symbol-Digit Modalities Test), and cerebral blood flow (CBF) measured by MRI. An exploratory post-hoc subgroup analysis was also conducted in nine participants who voluntarily received an additional KXA session in a self-controlled manner. Results In the main trial, KXA administration was associated with a non-significant reduction in total LLS and a decrease in AMS incidence from 50% (placebo) to 30% (KXA). No significant differences were observed in SpO 2 , cognitive tests, or global CBF. However, the KXA group showed a smaller increase and more stable heart rate profile over time. Exploratory regional CBF analyses revealed reduced perfusion in selected subregions of the limbic and control networks in the KXA group ( p < 0.05 uncorrected). In the post-hoc self-controlled subgroup (n = 9), KXA significantly reduced total LLS ( p = 0.037) and decreased AMS incidence from 44% to 0%, with trends toward improved cognitive performance. Conclusion KXA shows preliminary potential for alleviating AMS symptoms under simulated high-altitude conditions, possibly through cardiac and regional cerebrovascular modulation. These findings support further investigation in larger, randomized controlled trials in real-world high-altitude settings to confirm efficacy and clarify the underlying mechanisms. Chinese clinical trial registry ChiCTR2500105469.

Source: Frontiers in Physiology

DOI: 10.3389/fphys.2026.1834301