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The effect of Buyang Huanwu Decoction on improving the cognitive impairment of diabetic encephalopathy and the molecular mechanism of protecting blood brain barrier

The effect of Buyang Huanwu Decoction on improving the cognitive impairment of diabetic encephalopathy and the molecular mechanism of protecting blood brain barrier

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055242
Enrollment
Unknown
Registered
2022-01-04
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic encephalopathy cognitive dysfunction

Interventions

Experimental group:Give patients Buyang Huanwu decoction
Control group:Give patients a placebo with no treatment effect patients placebo that had no therapeutic effect

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 55 to 75 years, meeting the diagnostic criteria for T2DM established by WHO in 1999; 2. HbA1c range: 6.5-9%; 3. Comply with the standard of TCM syndrome differentiation and diagnosis; 4. Montreal Cognitive Assessment Scale (MoCA) score < 26 points, complex instrumental daily activities may be slightly impaired, normal activities of daily living, and do not meet the diagnostic criteria for dementia; 5. Able to communicate well with researchers and comply with the entire experimental requirements; 6. Exclude other factors that cause cognitive dysfunction.

Exclusion criteria

Exclusion criteria: 1. New diseases that may cause changes in blood sugar within 3 months, such as infection, myocardial infarction, tumor, inflammation, trauma and other severe stress states, as well as hyperthyroidism, hypothyroidism, hypercortisolism, acromegaly, etc.; 2. Those with cognitive impairment caused by taking drugs that increase blood sugar or improve cognition or taking neuropsychiatric drugs within 3 months. 3. Severe liver disease (including chronic persistent hepatitis, liver cirrhosis, or both positive for hepatitis B virus surface antigen and abnormal liver transaminase (serum alanine aminotransferase or aspartate aminotransferase concentration > 2.5 times the upper limit of normal); 4. History of severe renal disease or serum creatinine > 133µmol/l; 5. Known blood system disease or hemoglobin < 90 g/L (9 g/dL); 6. Hypoproteinemia, serum albumin < 35g/L; 7. Blood transfusion or blood donation within the past 3 months; 8. Severe organic diseases, including cancer, coronary heart disease, myocardial infarction or stroke, or cognitive dysfunction caused by trauma, poisoning, alcoholism, Parkinson's disease, polymyositis, etc.; 9. The evaluation of cognitive function in patients with major depression, schizophrenia and other mental diseases or delirium; 10. Infectious diseases, including tuberculosis and AIDS; and alcoholism; 11. Participated in other studies or observational investigators at the same time or within 3 months; 12. Those who cannot cooperate with the tester for various reasons.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale Score;Mini-Mental State Examination Scale Score;

Secondary

MeasureTime frame
Glycosylated albumin;Blood glucose;

Countries

China

Contacts

Public ContactXu Shunjiang

The First Hospital of Hebei Medical University

sjxu66@sina.com+86 18633889913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026