Chronic complications of diabetes mellitus
Conditions
Interventions
intervention group:Basic treatment + Ginkgo Leaf Tablets + Mecobalamin Capsules + Tangshen'an Granules
control group:Basic treatment + Ginkgo Leaf Tablets + Mecobalamin Capsules + Placebo
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) According to the 1999 WHO criteria participants meet the diagnostic standards for diabetes. (2) Based on the "Diagnostic and Therapeutic Standards for Diabetic Neurovascular Coupling Injury" participants fulfill the diagnostic criteria for mild to moderate diabetic neurovascular coupling injury. (3) According to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition)" and the MCI diagnostic procedure established by the European Alzheimer's Disease (AD) Consortium in 2011 participants meet the diagnostic criteria for one of the following three conditions: 1) Diabetic retinopathy classified as mild to moderate non-proliferative (affecting at least one eye); 2) DSPN (distal symmetric polyneuropathy); 3) Diabetes mellitus with cognitive impairment staged as MCI (mild cognitive impairment). (4) From the perspective of Traditional Chinese Medicine syndrome differentiation participants are diagnosed with kidney deficiency and blood stagnation syndrome. (5) Glycated hemoglobin = 9%. (6) Age range: 18-70 years with no gender restriction. (7) Signed patient informed consent form.
Exclusion criteria
Exclusion criteria: (1) Retinopathy (such as retinal vein occlusion age-related macular degeneration etc.) peripheral neuropathy (such as cervical and lumbar spine diseases Guillain-Barre syndrome vitamin B12 deficiency etc.) and cognitive dysfunction (such as endocrine and metabolic dysfunction sleep disorders etc.) caused by other etiologies. (2) Concurrent acute complications of diabetes (such as diabetic ketoacidosis diabetic hyperosmolar nonketotic syndrome etc.) or severe chronic complications (such as diabetic nephropathy with nephrotic syndrome diabetic lower limb artery occlusion etc.). (3) Individuals with severe dysfunction of the heart liver kidney or other organs or those with autoimmune diseases. (4) Individuals with mental illness intellectual disability or other conditions that prevent them from cooperating with the completion of this trial. (5) Individuals with allergic constitution or known allergies to drugs used in this study or those who are intolerant to these drugs. (6) Individuals who have participated in other trials within the past three months or are currently participating in other trials. (7) Women who are preparing for pregnancy pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation index of neurovascular coupling injury in diabetes:(1)Retinal nerve fiber layer thickness(RNFL);Evaluation index of neurovascular coupling injury in diabetes:(2)Montreal Cognitive Assessment(MoCA);Evaluation index of neurovascular coupling injury in diabetes:(3)Toronto Clinical Scoring System(TCSS);Evaluation index of neurovascular coupling injury in diabetes:(4)Mini - Mental State Examination(MMSE);Evaluation index of neurovascular coupling injury in diabetes:(5)Visual - Evoked Potential(VEP);Evaluation index of neurovascular coupling injury in diabetes:(6)Foveal avascular zone(FAZ);Evaluation index of neurovascular coupling injury in diabetes:(7)Corneal nerve fiber length(CNFL);Evaluation index of neurovascular coupling injury in diabetes:(8)gray matter volume(GAV);Evaluation index of neurovascular coupling injury in diabetes:(9)electroretinogram(ERG); | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose metabolism indicators:1)hemoglobin A1c(HbA1c);Glucose metabolism indicators:3)2 - hour post - prandial blood glucose;Symptom scores in traditional Chinese medicine;Glucose metabolism indicators:2)Fasting blood glucose;Quality of Life Scale (SF-36); | — |
Countries
China
Contacts
Public Contacthejiang ye
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed