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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.
Diabetes Mellitus
Diabetic Retinopathy
Cognitive Impairment
Neurovascular Coupling
hypoglycemic treatment
Tangshen'an Granules
Ginkgo Leaf Tablets
Mecobalamin Tablets
placebo
PHASE2
Diabetes mellitus(DM) is a prevalent condition that often leads to neurovascular coupling impairment (NCI), which has been shown to be intimately associated with diabetic retinopathy and cognitive decline. Given the critical need for early diagnosis and effective treatment, eye-brain multimodal imaging(MMI) technology has emerged as a promising tool in this field. This study focuses on establishing a comprehensive and standardized approach for diagnosing and treating diabetic NCI through the utilization of eye-brain MMI technology accompanied by assessing the effectiveness and potential therapeutic benefits of the traditional Chinese medicine compound, Tangshen'an Granule, in the management of diabetic NCI. A pool of standard diagnostic and therapeutic entries for diabetic NCI syndromes using eye-brain MMI technology is planned to be established through database retrieval and refined by expert questionnaire surveys to formulate the relevant standards. A multicenter, randomized, double-blind, placebo-controlled clinical evaluation study of Tangshen'an Granules in treating diabetic NCI (kidney deficiency and blood stasis syndrome) patients from specific hospitals will be conducted. Diagnostic criteria involve diabetes diagnosis and specific requirements of multiple eye-brain imaging and cognitive assessment tools. Eligibility criteria include inclusion and exclusion conditions. Randomization and blinding are properly implemented. The intervention includes basic therapy with different drug administrations in the experimental and control groups. The trial lasts 24 weeks. Primary outcomes are evaluated by various eye-brain imaging and cognitive assessment means. Secondary outcomes involve TCM symptom scores, glycemic indicators, and quality of life questionnaire. Safety indicators are monitored. Data is analyzed using Intent-To-Treat (ITT) analysis. The study protocol has been approved by the Ethics Committee of the Hospital of Chengdu University of Traditional Chinese Medicine(ethical approval number:2023KL-056). Informed consent is planned to be obtained from all participants. The study results will be reported in academic meetings and peer-reviewed journals to promote the development of diagnostic and treatment standards for diabetic NCI.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 160 participants |
| Masking : | DOUBLE |
| Masking Description : | The randomization sequence is crafted by statistical experts uninvolved in the trial's execution, utilizing SAS9.4 software with a predefined seed and an appropriately chosen block length. To ensure consistency, a third-party manufacturer is contracted to produce both the experimental drug and placebo, adhering to uniform labeling and packaging standards. Subsequently, a pharmacist independent of the trial's operational team blinds the medications in accordance with the established randomization sequence. The investigators dispense the drugs sequentially, adhering to the assigned drug numbers and the chronological order of patient enrollment. |
| Primary Purpose : | TREATMENT |
| Official Title : | 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 |
| Actual Study Start Date : | 2025-05-01 |
| Estimated Primary Completion Date : | 2026-05-01 |
| Estimated Study Completion Date : | 2026-12-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072
Not yet recruiting
Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine
D E sample, Sichuan, China, 618000
Not yet recruiting
Guangyuan North Sichuan Diabetes Specialty Hospital
GU case G officer, Sichuan, China, 628000