Effects and Potential Mechanisms of Shanyu Pill in Older Adults With Sarcopenia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Based on the Gut-Muscle-Brain Axis

Sarcopenia is an age-related condition characterized by progressive loss of muscle mass, muscle strength, and physical function. It may also be associated with impaired cognitive function. Effective treatment options for sarcopenia remain limited. This multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effects of Shanyu Pill in older adults with sarcopenia. A total of 192 participants are randomly assigned in a 1:1 ratio to receive either Shanyu Pill or placebo for 24 weeks. A long-term follow-up assessment is scheduled 2 years after completion of the 24-week intervention. The primary outcome is the change in appendicular skeletal muscle mass index (ASMI) from baseline to week 24. Other assessments include muscle strength, physical performance, cognitive function, and traditional Chinese medicine syndrome severity assessed using the Spleen Qi Deficiency Syndrome Score. Musculoskeletal ultrasound, functional near-infrared spectroscopy, gut microbiota analysis, and untargeted metabolomics are also used in subsets of participants to explore potential mechanisms associated with the effects of Shanyu Pill, including possible interactions within the gut-muscle-brain axis.