{"type":"trials","record":{"id":28370,"source_id":"clinicaltrials-gov","external_id":"NCT07012746","title":"A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss","brief_summary":"The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Yilai Shu","enrollment":60,"countries":["China"],"start_date":"2025-06-07","completion_date":"2027-04-01","last_update_date":"2025-06-10","source_url":"https://clinicaltrials.gov/study/NCT07012746","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. 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":null,"age_range":"65 Years to 75 Years","comparator":"Placebo group","organization":"Eye & ENT Hospital of Fudan University","interventions":["TJ0113 capsules","Placebo capsules"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss — Baseline, weeks 1, 4, 12, 24, and…","Speech Intelligibility - Word Recognition in Quiet and Noise — From baseline to 4, 12 ,24 weeks","Pure Tone Audiometry (PTA) — From baseline to 4, 12 ,24 weeks","Individual's health-related quality of life (HRQOL) — From baseline to 4, 12 ,24 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Age Related Hearing Loss","Deafness","TJ0113 capsules","Placebo capsules"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: age-related hearing loss.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct07012746","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-06-07 to 2027-04-01","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":"2026-09-25T06:25:04.659Z","intervention":["TJ0113 capsules","Placebo capsules"],"participants":60,"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":["Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss — Baseline, weeks 1, 4, 12, 24, and…","Speech Intelligibility - Word Recognition in Quiet and Noise — From baseline to 4, 12 ,24 weeks","Pure Tone Audiometry (PTA) — From baseline to 4, 12 ,24 weeks","Individual's health-related quality of life (HRQOL) — From baseline to 4, 12 ,24 weeks"],"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: age-related hearing loss.","Abstract contains controlled term: age-related hearing loss.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title 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/28370","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}