SarcopeniaNCT05919368
Effects of Shanyu Pill in Older Adults With Sarcopenia
A study testing Shanyu pill in people with Sarcopenia, run by Fujian University of Traditional Chinese Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Shanyu pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 3 sitesChina
- Study dates
- 17 Jul 2023to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350003
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350003
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: 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.
Read the detailed description
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.
The primary outcome is the change in appendicular skeletal muscle mass index (ASMI) from baseline to week 24. Secondary outcomes include handgrip strength, five-times sit-to-stand test performance, gait speed, 6-minute walk distance, Short Physical Performance Battery (SPPB) score, Timed Up and Go test completion time, Montreal Cognitive Assessment (MoCA) score, Stroop Color-Word Test completion time and accuracy, and traditional Chinese medicine syndrome severity assessed using the Spleen Qi Deficiency Syndrome Score.
Mechanistic assessments are performed in subsets of participants. Musculoskeletal ultrasound is used to assess skeletal muscle morphology and related characteristics. Functional near-infrared spectroscopy (fNIRS), combined with motor-cognitive dual-task gait assessments, is used to investigate cortical hemodynamic responses and their associations with clinical outcomes.
Gut microbiota profiling using 16S rRNA gene sequencing and untargeted metabolomic analyses of serum and fecal samples are also performed in subsets of participants to characterize changes in gut microbial composition and metabolic profiles. The fNIRS, gut microbiota, and metabolomic assessments are scheduled at baseline, week 24, and 2 years after completion of the 24-week intervention. These assessments are used to explore potential biological mechanisms associated with the effects of Shanyu Pill, including possible interactions among the gut, skeletal muscle, and brain.
The study protocol is approved by the Medical Ethics Committee of the Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine (Approval No. SPHFJP-T2023007-02), the Ethics Committee of the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine (Approval No. 2023KY-051-001), and the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (Approval No. 2023ZSLYEC-669).
- Conditions
- Sarcopenia
- Being tested
- Shanyu pill, Placebo
- Keywords
- Traditional Chinese Medicine, Shanyu Pill, Gut Microbiota, Gut-Muscle-Brain Axis, Functional Near-Infrared Spectroscopy, Untargeted Metabolomics, Dual-Task Gait, Cognitive Function
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanyu pillDietary supplement
It consists of Chinese yam, Atractylodes macrocephala, and ginseng.
PlaceboDietary supplement
It consists of corn starch and dextrin
| Study group | Role | What they receive |
|---|---|---|
| Shanyu pill group | Experimental | It consists of Chinese yam, Atractylodes macrocephala, and ginseng. Receives: Dietary Supplement: Shanyu pill |
| Placebo group | Placebo comparator | It consists of corn starch and dextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Secondary outcomes (13)
Change From Baseline in Handgrip Strength
Handgrip strength is measured using a handgrip dynamometer and reported in kilograms (kg), with higher values indicating greater muscle strength.
Measured: 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
Lower-extremity functional strength is assessed using the five-times sit-to-stand test. Completion time is recorded in seconds, with a shorter completion time indicating better performance.
Measured: 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
Traditional Chinese medicine syndrome severity is assessed using the Spleen Qi Deficiency Syndrome Score. The scale evaluates predefined signs and symptoms associated with spleen qi deficiency syndrome, and a total syndrome score is calculated according to the prespecified scoring criteria. Higher scores indicate greater severity of spleen qi deficiency syndrome.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gut Microbiota Composition
Gut microbiota composition is assessed using 16S rRNA gene sequencing of fecal samples. Changes in microbial community structure are evaluated using measures of microbial diversity and the relative abundance of bacterial taxa to characterize intervention-related alterations in the gut microbiota.
Measured: 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
Cortical hemodynamic responses are assessed using functional near-infrared spectroscopy (fNIRS) during motor-cognitive dual-task performance. Changes in cerebral oxygenation, including oxygenated hemoglobin responses in prefrontal and motor-related cortical regions, are evaluated to characterize intervention-related changes in cortical activation and brain functional responses.
Measured: Baseline, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gait Speed
Gait speed is measured in meters per second (m/s), with higher values indicating better walking performance.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in 6-Minute Walk Distance
Functional exercise capacity is assessed using the 6-minute walk test. The total distance walked is recorded in meters, with a longer distance indicating better exercise capacity.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Short Physical Performance Battery Score
Physical performance is assessed using the Short Physical Performance Battery (SPPB). The total score ranges from 0 to 12, with higher scores indicating better lower-extremity physical performance.
Measured: 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
Mobility is assessed using the Timed Up and Go (TUG) test. Completion time is recorded in seconds, with a shorter completion time indicating better mobility.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Montreal Cognitive Assessment Score
Global cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.
Measured: 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
Executive function and inhibitory control are assessed using the Stroop Color-Word Test. Completion time is recorded in seconds, with shorter completion time indicating better performance.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Stroop Color-Word Test Accuracy
Executive function and inhibitory control are assessed using the Stroop Color-Word Test. Accuracy is calculated as the percentage of correct responses, with higher percentages indicating better performance.
Measured: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics
Untargeted metabolomics is performed on serum and fecal samples using liquid chromatography-mass spectrometry. Metabolite abundance is assessed semi-quantitatively based on LC-MS peak signals after XCMS preprocessing, internal-standard correction, and quality-control filtering. Changes from baseline are used to characterize intervention-related metabolic alterations.
Measured: Baseline, Week 24, and 2 years after completion of the 24-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start17 Jul 2023
- Primary completion10 Dec 2024
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizhen Liu, Fujian University of Traditional Chinese Medicine
- Investigators
- Zhizhen Liu, Principal investigator, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919368
- Sponsor's protocol ID
- KFKT-2022-012
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05919368
- Acronym / sponsor ID
- KFKT-2022-012
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Fujian University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The primary outcome is the change in appendicular skeletal muscle mass index (ASMI) from baseline to week 24. Secondary outcomes include handgrip strength, five-times sit-to-stand test performance, gait speed, 6-minute walk distance, Short Physical Performance Battery (SPPB) score, Timed Up and Go test completion time, Montreal Cognitive Assessment (MoCA) score, Stroop Color-Word Test completion time and accuracy, and traditional Chinese medicine syndrome severity assessed using the Spleen Qi Deficiency Syndrome Score.
Mechanistic assessments are performed in subsets of participants. Musculoskeletal ultrasound is used to assess skeletal muscle morphology and related characteristics. Functional near-infrared spectroscopy (fNIRS), combined with motor-cognitive dual-task gait assessments, is used to investigate cortical hemodynamic responses and their associations with clinical outcomes.
Gut microbiota profiling using 16S rRNA gene sequencing and untargeted metabolomic analyses of serum and fecal samples are also performed in subsets of participants to characterize changes in gut microbial composition and metabolic profiles. The fNIRS, gut microbiota, and metabolomic assessments are scheduled at baseline, week 24, and 2 years after completion of the 24-week intervention. These assessments are used to explore potential biological mechanisms associated with the effects of Shanyu Pill, including possible interactions among the gut, skeletal muscle, and brain.
The study protocol is approved by the Medical Ethics Committee of the Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine (Approval No. SPHFJP-T2023007-02), the Ethics Committee of the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine (Approval No. 2023KY-051-001), and the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (Approval No. 2023ZSLYEC-669).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shanyu pill group | Experimental | Dietary Supplement: Shanyu pillIt consists of Chinese yam, Atractylodes macrocephala, and ginseng. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboIt consists of corn starch and dextrin |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shanyu pillIt consists of Chinese yam, Atractylodes macrocephala, and ginseng. | Dietary supplement | Shanyu pill group |
| PlaceboIt consists of corn starch and dextrin | Dietary supplement | Placebo group |
Primary outcome
Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI)
Time frame: 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.
13 secondary outcomes
Change From Baseline in Handgrip Strength
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gut Microbiota Composition
Time frame: 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
Time frame: Baseline, Week 24, and 2 years after completion of the 24-week intervention
Change From Baseline in Gait Speed
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in 6-Minute Walk Distance
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Short Physical Performance Battery Score
Time frame: 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
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Montreal Cognitive Assessment Score
Time frame: 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
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Stroop Color-Word Test Accuracy
Time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention.
Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics
Time frame: Baseline, Week 24, and 2 years after completion of the 24-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhizhen Liu principal investigator
Fujian University of Traditional Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shanyu pill in people with Sarcopenia, run by Fujian University of Traditional Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI) (time frame: Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.