NCT06813274Not yet recruitingPhase 2
Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling
Multicenter, Double Blind, Randomized, Placebo-controlled Trial to Exploring the Role of Eye-Brain Multimodal Imaging in Diagnosing and Treating Neurovascular Coupling Impairment in Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 26 Jan 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Hejiang Ye
- Diseases
- Diabetic eye disease
- NCT number
- NCT06813274
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 1 Jan 2026 to the primary completion date, 1 Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Participants exhibiting retinopathy induced by alternative etiological factors (including retinal vein occlusion, age-related macular degeneration(AMD), alongside cognitive impairments stemming from endocrine-metabolic disturbances, sleep disorders.
- Participants suffering from acute diabetic complications (such as diabetic ketoacidosis, hyperosmolar hyperglycemic state).
- Participants with significant dysfunction in the heart, liver, kidney, or autoimmune disorders.
- ④Participants unable to cooperate due to mental health issues, intellectual disabilities, or similar conditions that impede their participation in the trial.
- ⑤Participants who are allergic to the intervention used in this study.
- ⑥Participants who have engaged in other trials within the past three months or are currently enrolled in another study.
- ⑦Female participants who are in the process of trying to conceive, are pregnant, or are lactating.
Who the study is looking for
- Participants who comply with the diagnostic criteria for DM according to the World Health Organization in 1999.
- Participants who fulfill the diagnostic criteria for diabetic NCI.
- ③ Participants who diagnosed with the syndrome of kidney deficiency and blood stasis according to TCM syndrome differentiation.
- ④ Participants who have a glycated hemoglobin(HbA1c) level of ≤9%.
- ⑤ Participants who are aged between 18 and 70 years inclusive, with no gender preference.
- ⑥Participants who sign informed consent form.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of Chengdu University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Guangyuan North Sichuan Diabetes Specialty Hospital Coordinator of this site? Confirm its status | Guangyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.