{"type":"trials","record":{"id":28359,"source_id":"clinicaltrials-gov","external_id":"NCT05125081","title":"Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency","brief_summary":"The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Shanghai Jiao Tong University School of Medicine","enrollment":120,"countries":["China"],"start_date":"2022-01-25","completion_date":"2024-12-25","last_update_date":"2026-01-07","source_url":"https://clinicaltrials.gov/study/NCT05125081","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.50034+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":"RLDP","age_range":"65 Years to 75 Years","comparator":"placebo group","organization":"Shanghai Jiao Tong University School of Medicine","interventions":["Liuwei Dihuang Pill (marketed product in China)","Liuwei Dihuang Pill（placebo ）"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in PB-Max after 48 weeks of treatment — 48 weeks","Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment — 24 weeks，48 weeks","Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment — 24 weeks，48 weeks","Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatmen…","Change in Tinnitus Handicap Inventory（THI）after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment — 12 weeks，24 week…","Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment — 12 weeks，24…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Presbycusis","Age-related Hearing Loss","Hearing Disorders and Deafness","Liuwei Dihuang Pill (marketed product in China)","Liuwei Dihuang Pill（placebo ）"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: presbycusis.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct05125081","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-25 to 2024-12-25","comparator":"placebo group","confidence":"structured-source","population":"ALL · 65 Years to 75 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":"2026-09-25T06:25:04.656Z","intervention":["Liuwei Dihuang Pill (marketed product in China)","Liuwei Dihuang Pill（placebo ）"],"participants":120,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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 in PB-Max after 48 weeks of treatment — 48 weeks","Change in Speech recognition threshold (SRT) after 24 weeks and 48 weeks of treatment — 24 weeks，48 weeks","Change in Pure Tone Average (PTA) after 24 weeks and 48 weeks of treatment — 24 weeks，48 weeks","Change in Shen (Kidney)-Yin Deficiency Syndrome Questionnaire after 12 weeks，24 weeks，36 weeks and 48 weeks of treatmen…","Change in Tinnitus Handicap Inventory（THI）after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment — 12 weeks，24 week…","Change in Mini-mental State Examination (MMSE) after 12 weeks，24 weeks，36 weeks and 48 weeks of treatment — 12 weeks，24…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Title contains controlled term: presbycusis.","Abstract contains controlled term: presbycusis.","Source terminology contains: age-related hearing loss, presbycusis.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","controlled context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28359","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}