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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
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005496
Enrollment
Unknown
Registered
2022-01-04
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-20

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

placebo group:given patients placebo that had no therapeutic effect
BH group:Give patients buyang huanwu decoction

Sponsors

The first hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 55 to 75 met the diagnostic criteria for T2DM formulated by WHO in 1999; (2) HbA1c range: 6.5-9%; (3) Conforming to the criteria of TCM syndrome differentiation (4) Montreal Cognitive Assessment Scale (MoCA) score <26 points, complex instrumental daily ability may be slightly impaired, daily living ability normal, does not meet the diagnostic criteria for dementia (5) Able to communicate well with researchers and comply with the requirements of the whole experiment. (6)Other causes of cognitive dysfunction have been ruled out.

Exclusion criteria

Exclusion criteria: (1) New diseases that may cause blood glucose changes within 3 months, such as infection, myocardial infarction, tumor, inflammation, trauma and other severe stress states, as well as hyperthyroidism, hypothyroidism, hypercortisolism and acromegaly; (2) Cognitive impairment caused by taking drugs that raise blood glucose or improve cognition or neuropsychiatric drugs within 3 months. (3) severe liver disease (including chronic persistent hepatitis, cirrhosis or simultaneous hepatitis B virus surface antigen positive and abnormal liver transaminase (serum alanine aminotransferase or aspartate aminotransferase concentration > 2.5 times the normal upper limit); (4) history of severe kidney disease or serum creatinine & GT; 133 mu mol/l; (5) known diseases of blood system or hemoglobin <90 g/L (9g/dL); (6) hypoproteinemia, serum albumin <35g/L; (7) Blood transfusion or blood donation within the last 3 months; (8) Serious organic diseases, including cancer, coronary heart disease, myocardial infarction or stroke, or cognitive impairment caused by trauma, poisoning, alcoholism, Parkinson's disease, polymyositis, etc.; (9) Assessment of cognitive function affected by severe depression, schizophrenia and other mental diseases or delirium; (10) Infectious diseases, including tuberculosis and AIDS; And alcoholism; (11) Participated in other studies or observational researchers at the same time or within 3 months; (12)Unable to cooperate with the tester for various reasons.

Design outcomes

Primary

MeasureTime frame
MoCA score;MMSE score;

Secondary

MeasureTime frame
Glycosylated albumin;blood glucose;

Countries

China

Contacts

Public ContactShunjiang Xu

The first hospital of Hebei Medical University

sjxu66@sina.com18633889913

Outcome results

None listed

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