Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders

Qing Ni

Status: Not yet enrolling

Conditions: Aging; Traditional Chinese Medicine; Metabolic Disorders; Diabete Mellitus; Randomized Controlled Trial

Treatments: Drug: Buyuan Zhixiao Formula; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06358118

2024-003-KY

Details and patient eligibility

About

The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.

The main questions it aims to answer are:

1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.

Participants will:

1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;
3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
4. Urine and serum samples were collected before and after treatment;

Enrollment: 240 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Age ≥65 years, irrespective of sex;
• 2.Individuals who meet the Western medical diagnostic criteria for type 2 diabetes mellitus (T2DM) in the elderly, with a hemoglobin A1c level of ≥7.0% in the past three months;
• 3.Compliance with the diagnostic criteria for abdominal obesity (waist circumference ≥90 cm for males and ≥85 cm for females);
• 4.Conformity to the diagnostic standards for hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
• 5.A history of dyslipidemia, where lipid levels have not reached the general control standards for elderly individuals with T2DM following oral lipid-lowering therapy (statins/bile acid sequestrants): LDL cholesterol <2.6 mmol/L and/or triglycerides <2.5 mmol/L;
• 6.Diagnosis of kidney deficiency and blood stasis according to traditional Chinese medicine, with the pattern type referring to the《Guidelines for Clinical Research of New Chinese Medicines》;
• 7.Willingness to sign an informed consent document.

Exclusion criteria

• 1.Exclusion of individuals who, within the past week, have experienced severe infections, acute cardiovascular or cerebrovascular events (such as acute cerebral infarction or myocardial infarction), significant trauma, acute pancreatitis, or other conditions that could precipitate stress-induced hyperglycemia. This also extends to those with concurrent endocrinopathies that may induce insulin resistance, such as Cushing's syndrome, hyperthyroidism, or pituitary growth hormone adenomas, as well as those currently receiving treatment with glucocorticoids or undergoing chemotherapy for malignancies.
• 2.Exclusion of individuals with a history of neurological disorders or psychiatric conditions that could impair cognitive function, as well as those with a history of medication use for these conditions.
• 3.Exclusion of individuals with severe complications of diabetes such as diabetic nephropathy in the uremic stage, or those with significant primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, as well as individuals diagnosed with cancer.
• 4.Exclusion of individuals with communication barriers that could affect the assessment of cognitive function, including severe impairments in speech, vision, and hearing.
• 5.Individuals who have participated in other pharmacological clinical trials within the past month.
• 6.Individuals who have insufficient understanding of this study, are unwilling to participate, or, based on the researchers' judgment, present a reduced likelihood of enrollment or poor compliance due to unstable work and living locations or other factors that could lead to loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

Take Buyuan Zhixiao Formula granules

Treatment:

Drug: Buyuan Zhixiao Formula

control group

Placebo Comparator group

Description:

Take a placebos

Treatment:

Drug: Placebo