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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Change from Baseline muscle mass at 6 months
研究概览
简要总结
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.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of Shanyu Pill and explore its potential mechanisms in older adults with sarcopenia and spleen qi deficiency syndrome. The trial includes a total of 192 participants, who are randomly assigned in a 1:1 ratio to receive either Shanyu Pill or placebo.
The trial is conducted at three study centers in China: the Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine, the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, and the Health Examination Center of the Sixth Affiliated Hospital of Sun Yat-sen University. Eligible participants are screened according to predefined inclusion and exclusion criteria, and written informed consent is obtained before enrollment.
The randomization sequence is generated by independent statistical personnel who are not involved in participant recruitment, intervention delivery, or outcome assessment. Participants, investigators, and outcome assessors are blinded to treatment allocation.
Shanyu Pill is a traditional Chinese medicine formula consisting mainly of Chinese yam, Atractylodes macrocephala, and ginseng. The placebo is primarily composed of corn starch and dextrin and is designed to resemble Shanyu Pill in appearance, shape, size, color, specification, packaging, and labeling to maintain blinding. Participants in both groups receive the assigned study medication orally three times daily, 5 days per week, for 24 weeks. Standardized health education is provided to both groups once per month during the intervention period.
Clinical assessments are scheduled at baseline, week 12, week 24, and 2 years after completion of the 24-week intervention. The assessment conducted 2 years after completion of the intervention is designed to evaluate long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Able to understand and cooperate with study procedures and voluntarily provide written informed consent.
排除标准
- •Severe neurological or musculoskeletal disorders that may affect motor function, including severe osteoporosis or severe osteoarthritis.
- •Severe cardiovascular, pulmonary, or psychiatric disorders; uncontrolled endocrine or metabolic diseases; or severe hepatic or renal dysfunction, including cirrhosis, renal failure, or dialysis.
- •Inability to communicate effectively with the investigators because of speech impairment or uncorrected hearing impairment.
- •Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <24, resulting in an inability to understand or complete the study questionnaires and assessments.
- •Use of growth hormone, estrogen, progesterone, testosterone, or related hormonal supplements within the previous 3 months, or presence of severe nutritional deficiency.
- •Participation in another clinical trial or a clinical trial involving traditional Chinese medicine supplements within the previous 3 months.
研究组 & 干预措施
Shanyu pill group
It consists of Chinese yam, Atractylodes macrocephala, and ginseng.
干预措施: Shanyu pill (Dietary Supplement)
Placebo group
It consists of corn starch and dextrin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from Baseline muscle mass at 6 months
时间窗: baseline，After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up
Double X-ray absorptiometry (DXA) was used to determine the skeletal mass (AMS) of the limbs of the patients. This method can accurately measure the total and local skeletal muscle mass, adipose tissue mass and bone mass, and calculate the muscle index = AMS/height 2 (kg/m2).
Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI)
时间窗: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Appendicular skeletal muscle mass (ASM) is assessed using dual-energy X-ray absorptiometry (DXA). ASM is calculated as the sum of lean soft tissue mass of the arms and legs. Appendicular skeletal muscle mass index (ASMI) is calculated as ASM divided by height squared (kg/m²). Changes in ASMI from baseline are assessed at week 12, week 24, and 2 years after completion of the 24-week intervention.The primary efficacy endpoint is the change in ASMI from baseline to week 24.
次要结局
- Change from Baseline cognition at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change from Baseline physical performance at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change from Baseline 16s rRNA at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change from Baseline handgrip strength at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change from Baseline small molecule metabolomics at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change from Baseline hemodynamics at 6 moths(After 12 weeks of intervention, after 24 weeks of intervention, and after 24 weeks of follow-up)
- Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics(Baseline, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Handgrip Strength(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention)
- Change From Baseline in Five-Times Sit-to-Stand Test Performance(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention)
- Change From Baseline in Traditional Chinese Medicine Syndrome Score for Spleen Qi Deficiency(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention)
- Change From Baseline in Gut Microbiota Composition(Baseline, Week 24, and 2 years after completion of the 24-week intervention)
- Change From Baseline in Cortical Hemodynamic Responses Assessed by Functional Near-Infrared Spectroscopy(Baseline, Week 24, and 2 years after completion of the 24-week intervention)
- Change From Baseline in Gait Speed(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in 6-Minute Walk Distance(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Short Physical Performance Battery Score(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Timed Up and Go Test Completion Time(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Montreal Cognitive Assessment Score(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Stroop Color-Word Test Completion Time(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
- Change From Baseline in Stroop Color-Word Test Accuracy(Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.)
研究者
Zhizhen Liu
Associate Professor
Fujian University of Traditional Chinese Medicine