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

Launched by QING NI · Apr 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Buyuan Zhixiao Formula to see how well it works for older adults with diabetes and other related health issues, such as high blood pressure and high cholesterol. The goal is to find out if this formula can help lower blood sugar levels, improve blood pressure, reduce fat in the blood, and even help with memory problems often seen in diabetes patients. Participants will be divided into two groups: one will receive the Buyuan Zhixiao Formula daily for six months, while the other group will take a placebo, which looks similar but has less active ingredient. Throughout the study, researchers will check participants’ blood sugar, cholesterol, and cognitive function to see how the treatment is working.

To be eligible for this trial, participants must be 65 years or older and have been diagnosed with type 2 diabetes. They should also have certain health conditions like abdominal obesity and high blood pressure. Participants can expect to take the study medication or placebo daily for six months, and they will have regular check-ups to monitor their health. It's important to know that there are some health conditions that could exclude someone from participating, such as severe infections or major heart problems, so potential participants will be carefully assessed before joining the study.

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Eligibility criteria

• 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.