Effects of Shanyu Pill in Older Adults With Sarcopenia

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.

Inclusion Criteria: 1. Age 60-85 years; meeting the Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia and the traditional Chinese medicine diagnostic criteria for spleen qi deficiency syndrome. 2. Able to understand and cooperate with study procedures and voluntarily provide written informed consent. Exclusion Criteria: 1. Severe neurological or musculoskeletal disorders that may affect motor function, including severe osteoporosis or severe osteoarthritis. 2. Severe cardiovascular, pulmonary, or psychiatric disorders; uncontrolled endocrine or metabolic diseases; or severe hepatic or renal dysfunction, including cirrhosis, renal failure, or dialysis. 3. Inability to communicate effectively with the investigators because of speech impairment or uncorrected hearing impairment. 4. Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \