Diabetes MellitusPhase 2TCM-MMINCT06813274
Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling
A Phase 2 study testing hypoglycemic treatment, Tangshen'an Granules and Ginkgo Leaf Tablets in people with Diabetes Mellitus and Diabetic Retinopathy, run by Hejiang Ye at 3 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Cognitive Impairment
- What is being tested?
- hypoglycemic treatment, Tangshen'an Granules and Ginkgo Leaf Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
Dingmeng Zhao, PhD, +86-18482111410, zhaodingmeng@stu.cdutcm.edu.cn
Xingyu Guo, MD
Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine
Deyang, Sichuan, 618000
Yunxi Xu, PhD, +86-15196052194, xuyunxi@stu.cdutcm.edu.cn
Hui Wang, MD
Guangyuan North Sichuan Diabetes Specialty Hospital
Guangyuan, Sichuan, 628000
Chuning Wang, PhD, +86-18482108534, wangchuning@stu.cdutcm.edu.cn
Xuan Han, MD
About this study
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
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 the detailed description
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.
- Being tested
- hypoglycemic treatment, Tangshen'an Granules, Ginkgo Leaf Tablets, Mecobalamin Tablets, placebo
- Keywords
- Eye-Brain Multimodal Imaging, Neurovascular Coupling Impairment, Diabetes Mellitus, Diabetic retinopathy, Diabetic Cognitive Impairment, Traditional Chinese Medicine
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoglycemic treatmentDrug
The diabetes management adheres to the "The 2025 Guidelines for Standards of Diabetes Care" issued by the American Diabetes Association (ADA).
Tangshen'an GranulesDrug
Tangshen'an Granules comprises a meticulously blended mix of Astragalus, Prepared Rehmannia Root, Dodder Seed, Kudzu Root, Millettia Speciosa Champ, Salviae Miltiorrhizae Radix et Rhizoma, Poria Cocos, and Polygala Tenuifolia. Tangshen'an Granules is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily.
Ginkgo Leaf TabletsDrug
The primary active ingredients of Ginkgo Leaf Tablets are ginkgo flavonoid glycosides and terpene lactones. The prescribed oral dosage is one tablet each time, administered three times a day.
Mecobalamin TabletsDrug
Mecobalamin Tablets primarily contain mecobalamin, which is a coenzyme-active form of vitamin B12. The prescribed oral dosage is 0.5mg, administered three times a day.
placeboDrug
The placebo contains 10% of the active ingredients in Tangshen'an Granules, formulated by controlling the concentration to mimic Tangshen'an Granules. The placebo is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants assigned to the experimental group will receive hypoglycemic treatment, accompanied by the administration of Tangshen'an Granules, Ginkgo Leaf Tablets, and Mecobalamin Capsules. Receives: Drug: hypoglycemic treatment; Drug: Tangshen'an Granules; Drug: Ginkgo Leaf Tablets; Drug: Mecobalamin Tablets |
| Control Group | Placebo comparator | Participants assigned to the control group will receive hypoglycemic treatment, accompanied by placebo, Ginkgo Leaf Tablets, and Mecobalamin Tablets. Receives: Drug: hypoglycemic treatment; Drug: Ginkgo Leaf Tablets; Drug: Mecobalamin Tablets; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness (RNFL)
The measurement of Retinal Nerve Fiber Layer Thickness (RNFL) is crucial in ophthalmology. Its main parameter is RNFL thickness, which represents the overall average thickness across the entire measured retinal area and is a fundamental metric for initial assessment with a decrease often linked to optic nerve damage.The measurement is often obtained using optical coherence tomography (OCT), a non-invasive imaging technique that delivers high-resolution, cross-sectional images of the retinal layers.
Measured: From the date of randomization until the end of the 24-week intervention period
Foveal Avascular Zone (FAZ)
Foveal Avascular Zone (FAZ) is a crucial parameter in retinal imaging, particularly for evaluating macular vascular integrity and diagnosing retinal vascular diseases, such as diabetic retinopathy. The key parameter is the FAZ area, which provides a detailed morphological and functional assessment of the foveal microvasculature. This measurement is commonly obtained using optical coherence tomography angiography (OCTA), which offers high-resolution, depth-resolved visualization of the retinal vasculature without the need for dye injection.
Measured: From the date of randomization until the end of the 24-week intervention period
Visual Evoked Potential (VEP)
Visual Evoked Potential (VEP) is a neurophysiological technique used to assess the functional integrity of the visual pathway, from the retina to the visual cortex, by measuring the electrical activity generated in response to visual stimuli. Its main parameter is the latency of the P100 wave, which represents the time delay (in milliseconds) between the presentation of a visual stimulus and the peak of the positive waveform occurring around 100 milliseconds post-stimulus. VEP measurement is typically conducted using an electroencephalogram system equipped with specialized software for stimulus presentation and signal analysis, making it an essential tool for evaluating visual pathway integrity, diagnosing neurological disorders, and monitoring disease progression or treatment efficacy.
Measured: From the date of randomization until the end of the 24-week intervention period
Gray matter volume (GMV)
Gray matter volume (GMV) is a pivotal aspect in neuroimaging research, particularly focusing on the structural properties of the brain. A primary parameter in GMV measurement is the absolute volume, which quantifies the volume occupied by neuronal cell bodies, dendrites, and synapses within specific brain regions. This parameter offers crucial insights into brain development, aging, and the pathophysiology of neurological and psychiatric disorders. The GMV is commonly measured by magnetic resonance imaging (MRI) scanners, specifically high-field strength MRI systems that provide superior spatial resolution and contrast.
Measured: From the date of randomization until the end of the 24-week intervention period
Montreal Cognitive Assessment（MoCA）score
The Montreal Cognitive Assessment (MoCA) score is a widely used cognitive screening tool designed to detect mild cognitive impairment and early stages of dementia. It assesses multiple cognitive domains, including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The MOCA scale will be downloaded from the official website (https://www.mocatest.org).The test consists of 30 items, with a maximum score of 30 points, and typically takes 10-15 minutes to administer. A score of 26 or above is generally considered normal, while scores below 26 may indicate cognitive impairment.The MoCA is administered by a trained clinician or researcher who scores the participant's performance based on standardized criteria, providing a comprehensive assessment of cognitive function.
Measured: From the date of randomization until the end of the 24-week intervention period
Mini - Mental State Examination（MMSE）score
The Mini-Mental State Examination (MMSE) score is a widely utilized cognitive screening instrument designed to assess cognitive impairment. It evaluates multiple cognitive domains, including orientation, memory, attention, language, and visuospatial abilities, through a series of questions and tasks. The MMSE will be downloaded from the official website at https://www.parinc.com.The MMSE, administered by a trained investigator, consists of 30 items, with a maximum score of 30 points, and typically takes 5-10 minutes to test. A score of below 24 often indicates cognitive impairment.
Measured: From the date of randomization until the end of the 24-week intervention period
Secondary outcomes (4)
Symptom scores in traditional Chinese medicine
Symptom scores in Traditional Chinese Medicine (TCM) are a systematic approach to quantifying and evaluating clinical manifestations based on TCM theory. These scores, administered by a trained investigator, typically assess a range of symptoms, including but not limited to fatigue, pain, digestive issues, sleep disturbances, emotional states, and specific organ-related dysfunctions, through structured questionnaires or clinical observation. The degree can be scored from mild to severe.
Measured: From the date of randomization until the end of the 24-week intervention period
Glucose metabolism indicators:Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) is a critical biomarker used to assess long-term glycemic control in individuals with diabetes, reflecting the average blood glucose levels over the preceding 2-3 months. The measurement of HbA1c include high-performance liquid chromatography (HPLC), immunoassay, and affinity chromatography, each offering high precision and accuracy.
Measured: From the date of randomization until the end of the 24-week intervention period
Glucose metabolism indicators:Fasting blood glucose
Fasting Blood Glucose (FBG) is a fundamental test used to measure blood sugar levels after an individual has fasted for at least 8 hours. It is a key diagnostic tool for assessing glucose metabolism and identifying conditions such as diabetes mellitus, prediabetes, and insulin resistance.The measurement is performed using enzymatic methods, such as glucose oxidase or hexokinase assays, which provide high specificity and accuracy.
Measured: From the date of randomization until the end of the 24-week intervention period
Quality of Life Scale (SF-36)
The SF-36 is a widely utilized questionnaire that measures health-related quality of life including physical functioning, bodily pain, general health perceptions, vitality, social functioning and mental health. It employs a standardized set of questions with weighted response options, enabling the quantification of an individual's health status thus serving as a valuable tool in clinical research, healthcare evaluation, and policy-making.
Measured: From the date of randomization until the end of the 24-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a block randomization technique to allocate participants into groups, maintaining a 1:1 ratio between the experimental and control arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hejiang Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hejiang Ye, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813274
- Sponsor's protocol ID
- 2023ZD001
- Acronym
- TCM-MMI
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic data, including age, gender, and ethnicity of the participants. Baseline clinical data such as blood glucose levels, blood pressure, and diabetes duration. Imaging data from multimodaleye - brain imaging, which are anonymized and de - identified to protect patient privacy. Outcome data related to the assessment of diabetes neurovascular coupling, like TCM symptom scores and specific functional scores. Safety indicators, such as blood and urine routine tests, electrocardiogram
Publications
Mondal R, Deb S, Chowdhury D, Sarkar S, Guha Roy A, Shome G, Sarkar V, Lahiri D, Benito-Leon J. Neurometabolic substrate transport across brain barriers in diabetes mellitus: Implications for cognitive function and neurovascular health. Neurosci Lett. 2024 Nov 20;843:138028. doi: 10.1016/j.neulet.2024.138028. Epub 2024 Oct 24.
PubMed 39461703Martins B, Pires M, Ambrosio AF, Girao H, Fernandes R. Contribution of extracellular vesicles for the pathogenesis of retinal diseases: shedding light on blood-retinal barrier dysfunction. J Biomed Sci. 2024 May 10;31(1):48. doi: 10.1186/s12929-024-01036-3.
PubMed 38730462American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
PubMed 38078589
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06813274
- Acronym / sponsor ID
- TCM-MMI / 2023ZD001
- Keywords
- Eye-Brain Multimodal Imaging, Neurovascular Coupling Impairment, Diabetes Mellitus, Diabetic retinopathy, Diabetic Cognitive Impairment, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hejiang YeUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study adopts a block randomization technique to allocate participants into groups, maintaining a 1:1 ratio between the experimental and control arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: hypoglycemic treatment, Drug: Tangshen'an Granules, Drug: Ginkgo Leaf Tablets, Drug: Mecobalamin TabletsParticipants assigned to the experimental group will receive hypoglycemic treatment, accompanied by the administration of Tangshen'an Granules, Ginkgo Leaf Tablets, and Mecobalamin Capsules. |
| Control Group | Placebo comparator | Drug: hypoglycemic treatment, Drug: Ginkgo Leaf Tablets, Drug: Mecobalamin Tablets, Drug: placeboParticipants assigned to the control group will receive hypoglycemic treatment, accompanied by placebo, Ginkgo Leaf Tablets, and Mecobalamin Tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who comply with the diagnostic criteria for DM according to the World Health Organization in 1999.
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoglycemic treatmentThe diabetes management adheres to the "The 2025 Guidelines for Standards of Diabetes Care" issued by the American Diabetes Association (ADA). | Drug | Control Group, Intervention Group |
| Tangshen'an GranulesTangshen'an Granules comprises a meticulously blended mix of Astragalus, Prepared Rehmannia Root, Dodder Seed, Kudzu Root, Millettia Speciosa Champ, Salviae Miltiorrhizae Radix et Rhizoma, Poria Cocos, and Polygala Tenuifolia. Tangshen'an Granules is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily. | Drug | Intervention Group |
| Ginkgo Leaf TabletsThe primary active ingredients of Ginkgo Leaf Tablets are ginkgo flavonoid glycosides and terpene lactones. The prescribed oral dosage is one tablet each time, administered three times a day. | Drug | Control Group, Intervention Group |
| Mecobalamin TabletsMecobalamin Tablets primarily contain mecobalamin, which is a coenzyme-active form of vitamin B12. The prescribed oral dosage is 0.5mg, administered three times a day. | Drug | Control Group, Intervention Group |
| placeboThe placebo contains 10% of the active ingredients in Tangshen'an Granules, formulated by controlling the concentration to mimic Tangshen'an Granules. The placebo is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily. | Drug | Control Group |
Primary outcome
Retinal Nerve Fiber Layer Thickness (RNFL)
Time frame: From the date of randomization until the end of the 24-week intervention period
The measurement of Retinal Nerve Fiber Layer Thickness (RNFL) is crucial in ophthalmology. Its main parameter is RNFL thickness, which represents the overall average thickness across the entire measured retinal area and is a fundamental metric for initial assessment with a decrease often linked to optic nerve damage.The measurement is often obtained using optical coherence tomography (OCT), a non-invasive imaging technique that delivers high-resolution, cross-sectional images of the retinal layers.
Foveal Avascular Zone (FAZ)
Time frame: From the date of randomization until the end of the 24-week intervention period
Foveal Avascular Zone (FAZ) is a crucial parameter in retinal imaging, particularly for evaluating macular vascular integrity and diagnosing retinal vascular diseases, such as diabetic retinopathy. The key parameter is the FAZ area, which provides a detailed morphological and functional assessment of the foveal microvasculature. This measurement is commonly obtained using optical coherence tomography angiography (OCTA), which offers high-resolution, depth-resolved visualization of the retinal vasculature without the need for dye injection.
Visual Evoked Potential (VEP)
Time frame: From the date of randomization until the end of the 24-week intervention period
Visual Evoked Potential (VEP) is a neurophysiological technique used to assess the functional integrity of the visual pathway, from the retina to the visual cortex, by measuring the electrical activity generated in response to visual stimuli. Its main parameter is the latency of the P100 wave, which represents the time delay (in milliseconds) between the presentation of a visual stimulus and the peak of the positive waveform occurring around 100 milliseconds post-stimulus. VEP measurement is typically conducted using an electroencephalogram system equipped with specialized software for stimulus presentation and signal analysis, making it an essential tool for evaluating visual pathway integrity, diagnosing neurological disorders, and monitoring disease progression or treatment efficacy.
Gray matter volume (GMV)
Time frame: From the date of randomization until the end of the 24-week intervention period
Gray matter volume (GMV) is a pivotal aspect in neuroimaging research, particularly focusing on the structural properties of the brain. A primary parameter in GMV measurement is the absolute volume, which quantifies the volume occupied by neuronal cell bodies, dendrites, and synapses within specific brain regions. This parameter offers crucial insights into brain development, aging, and the pathophysiology of neurological and psychiatric disorders. The GMV is commonly measured by magnetic resonance imaging (MRI) scanners, specifically high-field strength MRI systems that provide superior spatial resolution and contrast.
Montreal Cognitive Assessment（MoCA）score
Time frame: From the date of randomization until the end of the 24-week intervention period
The Montreal Cognitive Assessment (MoCA) score is a widely used cognitive screening tool designed to detect mild cognitive impairment and early stages of dementia. It assesses multiple cognitive domains, including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The MOCA scale will be downloaded from the official website (https://www.mocatest.org).The test consists of 30 items, with a maximum score of 30 points, and typically takes 10-15 minutes to administer. A score of 26 or above is generally considered normal, while scores below 26 may indicate cognitive impairment.The MoCA is administered by a trained clinician or researcher who scores the participant's performance based on standardized criteria, providing a comprehensive assessment of cognitive function.
Mini - Mental State Examination（MMSE）score
Time frame: From the date of randomization until the end of the 24-week intervention period
The Mini-Mental State Examination (MMSE) score is a widely utilized cognitive screening instrument designed to assess cognitive impairment. It evaluates multiple cognitive domains, including orientation, memory, attention, language, and visuospatial abilities, through a series of questions and tasks. The MMSE will be downloaded from the official website at https://www.parinc.com.The MMSE, administered by a trained investigator, consists of 30 items, with a maximum score of 30 points, and typically takes 5-10 minutes to test. A score of below 24 often indicates cognitive impairment.
4 secondary outcomes
Symptom scores in traditional Chinese medicine
Time frame: From the date of randomization until the end of the 24-week intervention period
Glucose metabolism indicators:Hemoglobin A1c (HbA1c)
Time frame: From the date of randomization until the end of the 24-week intervention period
Glucose metabolism indicators:Fasting blood glucose
Time frame: From the date of randomization until the end of the 24-week intervention period
Quality of Life Scale (SF-36)
Time frame: From the date of randomization until the end of the 24-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 39461703Mondal R, Deb S, Chowdhury D, Sarkar S, Guha Roy A, Shome G, Sarkar V, Lahiri D, Benito-Leon J. Neurometabolic substrate transport across brain barriers in diabetes mellitus: Implications for cognitive function and neurovascular health. Neurosci Lett. 2024 Nov 20;843:138028. doi: 10.1016/j.neulet.2024.138028. Epub 2024 Oct 24.
- Background: PubMed 38730462Martins B, Pires M, Ambrosio AF, Girao H, Fernandes R. Contribution of extracellular vesicles for the pathogenesis of retinal diseases: shedding light on blood-retinal barrier dysfunction. J Biomed Sci. 2024 May 10;31(1):48. doi: 10.1186/s12929-024-01036-3.
- Background: PubMed 38078589American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
- Individual participant dataSharing planned: Yes. Demographic data, including age, gender, and ethnicity of the participants. Baseline clinical data such as blood glucose levels, blood pressure, and diabetes duration. Imaging data from multimodaleye - brain imaging, which are anonymized and de - identified to protect patient privacy. Outcome data related to the assessment of diabetes neurovascular coupling, like TCM symptom scores and specific functional scores. Safety indicators, such as blood and urine routine tests, electrocardiogram
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypoglycemic treatment, Tangshen'an Granules and Ginkgo Leaf Tablets in people with Diabetes Mellitus and Diabetic Retinopathy, run by Hejiang Ye at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hejiang Ye, Professor (+86-877867380, Hejiangye2024@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness (RNFL) (time frame: From the date of randomization until the end of the 24-week intervention period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813274, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.