{"type":"trials","record":{"id":31311,"source_id":"clinicaltrials-gov","external_id":"NCT06813274","title":"Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling","brief_summary":"This study intends to take the critical pathological mechanism of diabetic neurovascular coupling injury (NCI) as the starting point and utilize multi-modal imaging (MMI) technology of the eyes and brain as a means to conduct in-depth, integrated, and interdisciplinary research with Traditional Chinese Medicine (TCM) syndrome studies. The aim is to establish diagnostic and therapeutic standards for diabetic NCI, based on Eye-Brain Multimodal Imaging technology, providing objective and quantitative evidence for early disease diagnosis and therapeutic effect evaluation. Simultaneously, investigators will conduct multicenter, randomized, placebo-controlled, double-blind clinical trials to systematically investigate the clinical efficacy and safety of Tangshen'an Granule in preventing and treating diabetic NCI. By obtaining high-quality evidence-based data on TCM, this study aims to enhance the level of prevention and treatment with TCM and clinical service capabilities, thereby providing new ideas and directions for research.","overall_status":"Not Yet Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Hejiang Ye","enrollment":160,"countries":["China"],"start_date":"2026-01-01","completion_date":"2026-12-01","last_update_date":"2025-09-26","source_url":"https://clinicaltrials.gov/study/NCT06813274","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:20:09.878+00:00","metadata":{"sex":"ALL","acronym":"TCM-MMI","age_range":"18 Years to 70 Years","comparator":"Control Group","organization":"Chengdu University of Traditional Chinese Medicine","interventions":["hypoglycemic treatment","Tangshen'an Granules","Ginkgo Leaf Tablets","Mecobalamin Tablets","placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Retinal Nerve Fiber Layer Thickness (RNFL) — From the date of randomization until the end of the 24-week intervention p…","Foveal Avascular Zone (FAZ) — From the date of randomization until the end of the 24-week intervention period","Visual Evoked Potential (VEP) — From the date of randomization until the end of the 24-week intervention period","Gray matter volume (GMV) — From the date of randomization until the end of the 24-week intervention period","Montreal Cognitive Assessment（MoCA）score — From the date of randomization until the end of the 24-week intervention per…","Mini - Mental State Examination（MMSE）score — From the date of randomization until the end of the 24-week intervention p…","Symptom scores in traditional Chinese medicine — From the date of randomization until the end of the 24-week interventi…","Glucose metabolism indicators:Hemoglobin A1c (HbA1c) — From the date of randomization until the end of the 24-week inte…","Glucose metabolism indicators:Fasting blood glucose — From the date of randomization until the end of the 24-week inter…","Quality of Life Scale (SF-36) — From the date of randomization until the end of the 24-week intervention period"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Diabetes Mellitus","Diabetic Retinopathy","Cognitive Impairment","Neurovascular Coupling","hypoglycemic treatment","Tangshen'an Granules","Ginkgo Leaf Tablets","Mecobalamin Tablets","placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: neurovascular.","quality_checked_at":"2026-09-25T06:20:11.344357+00:00","duplicate_cluster_key":"id:nct06813274","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-01-01 to 2026-12-01","comparator":"Control Group","confidence":"structured-source","population":"ALL · 18 Years to 70 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":"2026-09-25T06:20:09.894Z","intervention":["hypoglycemic treatment","Tangshen'an Granules","Ginkgo Leaf Tablets","Mecobalamin Tablets","placebo"],"participants":160,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Retinal Nerve Fiber Layer Thickness (RNFL) — From the date of randomization until the end of the 24-week intervention p…","Foveal Avascular Zone (FAZ) — From the date of randomization until the end of the 24-week intervention period","Visual Evoked Potential (VEP) — From the date of randomization until the end of the 24-week intervention period","Gray matter volume (GMV) — From the date of randomization until the end of the 24-week intervention period","Montreal Cognitive Assessment（MoCA）score — From the date of randomization until the end of the 24-week intervention per…","Mini - Mental State Examination（MMSE）score — From the date of randomization until the end of the 24-week intervention p…","Symptom scores in traditional Chinese medicine — From the date of randomization until the end of the 24-week interventi…","Glucose metabolism indicators:Hemoglobin A1c (HbA1c) — From the date of randomization until the end of the 24-week inte…","Glucose metabolism indicators:Fasting blood glucose — From the date of randomization until the end of the 24-week inter…","Quality of Life Scale (SF-36) — From the date of randomization until the end of the 24-week intervention period"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"blood-brain-barrier-aging","is_published":true,"match_reasons":["Title contains controlled term: neurovascular.","Abstract contains controlled term: neurovascular.","Source terminology contains: neurovascular.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Blood-brain barrier ageing","slug":"blood-brain-barrier-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31311","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}