{"type":"trials","record":{"id":22206,"source_id":"clinicaltrials-gov","external_id":"NCT05919368","title":"Effects of Shanyu Pill in Older Adults With Sarcopenia","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.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Fujian University of Traditional Chinese Medicine","enrollment":192,"countries":["China"],"start_date":"2023-07-17","completion_date":"2026-12-10","last_update_date":"2026-09-04","source_url":"https://clinicaltrials.gov/study/NCT05919368","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:16.887272+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":"Placebo group","organization":"Fujian University of Traditional Chinese Medicine","interventions":["Shanyu pill","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI) — Baseline, Week 12, Week 24, and 2 years after…","Change From Baseline in Handgrip Strength — Baseline, Week 12, Week 24, and 2 years after completion of the 24-week int…","Change From Baseline in Five-Times Sit-to-Stand Test Performance — Baseline, Week 12, Week 24, and 2 years after comple…","Change From Baseline in Traditional Chinese Medicine Syndrome Score for Spleen Qi Deficiency — Baseline, Week 12, Week…","Change From Baseline in Gut Microbiota Composition — Baseline, Week 24, and 2 years after completion of the 24-week int…","Change From Baseline in Cortical Hemodynamic Responses Assessed by Functional Near-Infrared Spectroscopy — Baseline, We…","Change From Baseline in Gait Speed — Baseline, Week 12, Week 24, and 2 years after completion of the 24-week interventi…","Change From Baseline in 6-Minute Walk Distance — Baseline, Week 12, Week 24, and 2 years after completion of the 24-wee…","Change From Baseline in Short Physical Performance Battery Score — Baseline, Week 12, Week 24, and 2 years after comple…","Change From Baseline in Timed Up and Go Test Completion Time — Baseline, Week 12, Week 24, and 2 years after completion…","Change From Baseline in Montreal Cognitive Assessment Score — Baseline, Week 12, Week 24, and 2 years after completion…","Change From Baseline in Stroop Color-Word Test Completion Time — Baseline, Week 12, Week 24, and 2 years after completi…","Change From Baseline in Stroop Color-Word Test Accuracy — Baseline, Week 12, Week 24, and 2 years after completion of t…","Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics — Baseline, Week 24, and…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Sarcopenia","Shanyu pill","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct05919368","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-07-17 to 2026-12-10","comparator":"Placebo group","confidence":"structured-source","population":"ALL · 60 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:25.755Z","intervention":["Shanyu pill","Placebo"],"participants":192,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change From Baseline in Appendicular Skeletal Muscle Mass Index (ASMI) — Baseline, Week 12, Week 24, and 2 years after…","Change From Baseline in Handgrip Strength — Baseline, Week 12, Week 24, and 2 years after completion of the 24-week int…","Change From Baseline in Five-Times Sit-to-Stand Test Performance — Baseline, Week 12, Week 24, and 2 years after comple…","Change From Baseline in Traditional Chinese Medicine Syndrome Score for Spleen Qi Deficiency — Baseline, Week 12, Week…","Change From Baseline in Gut Microbiota Composition — Baseline, Week 24, and 2 years after completion of the 24-week int…","Change From Baseline in Cortical Hemodynamic Responses Assessed by Functional Near-Infrared Spectroscopy — Baseline, We…","Change From Baseline in Gait Speed — Baseline, Week 12, Week 24, and 2 years after completion of the 24-week interventi…","Change From Baseline in 6-Minute Walk Distance — Baseline, Week 12, Week 24, and 2 years after completion of the 24-wee…","Change From Baseline in Short Physical Performance Battery Score — Baseline, Week 12, Week 24, and 2 years after comple…","Change From Baseline in Timed Up and Go Test Completion Time — Baseline, Week 12, Week 24, and 2 years after completion…","Change From Baseline in Montreal Cognitive Assessment Score — Baseline, Week 12, Week 24, and 2 years after completion…","Change From Baseline in Stroop Color-Word Test Completion Time — Baseline, Week 12, Week 24, and 2 years after completi…","Change From Baseline in Stroop Color-Word Test Accuracy — Baseline, Week 12, Week 24, and 2 years after completion of t…","Change From Baseline in Relative Abundance of Metabolites Detected by Untargeted Metabolomics — Baseline, Week 24, and…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/22206","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}