Effects of Shanyu Pill in Older Adults With Sarcopenia

NCT05919368 | Active Not Recruiting DMC

• 1 other identifier: KFKT-2022-012
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sarcopenia

Keywords

Traditional Chinese Medicine; Shanyu Pill; Gut Microbiota; Gut-Muscle-Brain Axis; Functional Near-Infrared Spectroscopy; Untargeted Metabolomics; Dual-Task Gait; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI)

  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.

  Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention

Secondary Outcomes (13)

• 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

Study Arms (2)

Shanyu pill group

EXPERIMENTAL

It consists of Chinese yam, Atractylodes macrocephala, and ginseng.

Dietary Supplement: Shanyu pill

Placebo group

PLACEBO COMPARATOR

It consists of corn starch and dextrin

Dietary Supplement: Placebo

Interventions

Shanyu pill DIETARY_SUPPLEMENT

It consists of Chinese yam, Atractylodes macrocephala, and ginseng.

Shanyu pill group

Placebo DIETARY_SUPPLEMENT

It consists of corn starch and dextrin

Placebo group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian University of Traditional Chinese Medicine: lead

Study Sites (3)

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350003, China

Location

The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350003, China

Location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Zhizhen Liu

  Fujian University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 26, 2023
• Study Start: July 17, 2023
• Primary Completion: December 10, 2024
• Study Completion (Estimated): December 10, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)