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

Phase 1

• Conditions: Diabetic encephalopathy cognitive dysfunction

• Registration Number: ITMCTR2200005496
• Lead Sponsor: The first hospital of Hebei Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MoCA score;MMSE score;

Secondary Outcome Measures

Name	Time	Method
Glycosylated albumin;blood glucose;