Effects of Shanyu Pill in Older Adults With Sarcopenia
NCT05919368, Not applicable, Active not recruiting, Fujian University of Traditional Chinese Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Shanyu Pill in Older Adults With Sarcopenia | ClinicalTrials.gov |
| NCT number | NCT05919368 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 192 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fujian University of Traditional Chinese Medicine | ClinicalTrials.gov |
| Conditions | Sarcopenia | ClinicalTrials.gov |
| Interventions | Shanyu pill, Placebo | ClinicalTrials.gov |
| First posted | 2023-06-26 | ClinicalTrials.gov |
| Last updated | 2026-09-04 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI) | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Handgrip Strength | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention | Handgrip strength is measured using a handgrip dynamometer and reported in kilograms (kg), with higher values indicating greater muscle strength. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Gut Microbiota Composition | Baseline, Week 24, and 2 years after completion of the 24-week intervention | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Gait Speed | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention. | Gait speed is measured in meters per second (m/s), with higher values indicating better walking performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 6-Minute Walk Distance | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Short Physical Performance Battery Score | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Montreal Cognitive Assessment Score | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Stroop Color-Word Test Accuracy | Baseline, Week 12, Week 24, and 2 years after completion of the 24-week intervention. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)