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

N/ANot Yet RecruitingNCT06358118

Qing Ni240 enrolled

Overview

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;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Diabete Mellitus

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijin, Beijing Municipality, China

Cangzhou integrative medicine hospital

Hebei, China

Hohhot Mongolian Traditional Chinese Medicine Hospital

Neimeng, China

Binzhou Traditional Chinese Medicine Hospital

Shandong, China

Yantai Baishi Traditional Chinese Medicine Hospital

Shandong, China

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Outcomes

Primary Outcomes

HbA1c

unit：%

Time frame: Measured at 0, 3, 6, and 12 months respectively.

Secondary Outcomes

Fasting blood glucose

unit：mmol/l

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

2-hour postprandial blood glucose

unit：mmol/l

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

blood pressure

unit：mmHg

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

weight

unit：KG

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

waist circumference

unit：cm

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

BMI

unit：kg/m2

Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively

Total Cholesterol

unit：mmol/l