Tests Tangshen'an Granules for early brain and eye changes in diabetes
Tests Tangshen'an Granules against placebo in adults with diabetes and early brain blood-flow problems.
Plain-language title generated from the registry record
Registry title: Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling
Key facts
- Where
- Chengdu, Deyang, and Guangyuan, ChinaSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06813274, who can take part
Where in China
- Hospital of Chengdu University of Traditional Chinese MedicineChengdu, ChinaNo longer taking part
- Deyang Hospital Affiliated to Chengdu University of Traditional Chinese MedicineDeyang, ChinaNo longer taking part
- Guangyuan North Sichuan Diabetes Specialty HospitalGuangyuan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hejiang Ye
- Trial code
- NCT06813274
- Record updated
- 26 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.