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NCT06358118 | Not yet recruiting | Diabete Mellitus

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

QingNI

Information provided by (Responsible Party):

QingNI

Brief Summary:

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: What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity? 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: Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months； 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; Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events; Urine and serum samples were collected before and after treatment;

Condition or disease

Diabetes Mellitus

Aging

Metabolic Disorders

Traditional Chinese Medicine

Randomized Controlled Trial

Intervention/treatment

Buyuan Zhixiao Formula

Placebo

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 240 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : Clinical Research on Evidence Based Traditional Chinese Medicine for Elderly Diabetes Based on State Target Theory-Buyuan Zhixiao Fang in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders: Study Protocol for a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : May 6, 2024
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2025
Arm Intervention/treatment

Experimental: experimental group

take buy UA NZ Hi small formula granules

drug: B U yuan z Hi small formula

Placebo Comparator: control group

Take a placebos

Drug: Placebo
Ages Eligible for Study: 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders

Location Details

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

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, Beijing, China, 100053

Not yet recruiting

China,

Cangzhou integrative medicine hospital

Hebei, China,

Not yet recruiting

China,

Hohhot Mongolian Traditional Chinese Medicine Hospital

NE i Meng, China,

Not yet recruiting

China,

Binzhou Traditional Chinese Medicine Hospital

Shandong, China,

Not yet recruiting

China,

Yantai Baishi Traditional Chinese Medicine Hospital

Shandong, China,

Not yet recruiting

China,

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China,