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Effects of Xuezhikang vs Pravastatin on triglyceride level in patients with Type 2 Diabetes Mellitus and Dyslipidemia: a multicenter, prospective, randomized controlled study

Effects of Xuezhikang vs Pravastatin on triglyceride level in patients with Type 2 Diabetes Mellitus and Dyslipidemia: a multicenter, prospective, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046704
Enrollment
Unknown
Registered
2021-05-27
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus with Dyslipidemia

Interventions

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years. 2. Diagnosed type 2 diabetes patients, according to the "Diabetes Medical Diagnosis and Treatment Standards" established by the American Diabetes Association (ADA) in 2020, need to meet any of the following criteria: (1) Fasting plasma glucose >= 7.0mmol/L, fasting state means no calorie intake for at least 8 hours; (2) OGTT 2 hours plasma glucose >= 11.1mmol/L, OGTT method according to WHO standard, oral anhydrous glucose powder 75g; (3) HbA1c>=6.5%, HbA1c detection adopts NGSP and DCCT certification methods; (4) Patients with typical symptoms of hyperglycemia or risk of hyperglycemia, random blood glucose >= 11.1mmol/L, and treatment of diabetes under the guidance of an endocrinologist during the study period. 3. At least one of the following conditions exists: (1) History of type 2 diabetes >=10 years; (2) Smoking; (3) Obesity [BMI >= 28Kg/m^2, or waist circumference>=90cm (male) or >= 85cm (female)]; (4) Hypertension; (5) Fasting HDL-C = 2.6mmol/L in the past four weeks. 4. Abnormal blood lipids in the past 4 weeks must meet the following two conditions at the same time: (1) 1.7mmol/L <= Fasting TG < 5.6mmol/L; (2) 1.8mmol/L <= fasting LDL-C < 4.9mmol/L. 5. During the study period, the selected patients are willing to accept and comply with dietary education. 6. The patient must be able to comply with regular visits, treatment plans and all laboratory tests. 7. Sign informed consent and take the test voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from atherosclerotic cardiovascular diseases, including coronary atherosclerotic heart disease, ischemic stroke, transient ischemic attack, peripheral artery disease, etc.; 2. Patients who have taken lipid-lowering drugs in the past three months; 3. Diabetic patients who have not controlled their blood sugar well, that is, HbA1c%>=8.0%; 4. Active hepatitis or unexplained continuous increase in serum aminotransferase or serum aminotransferase level greater than 3 times the upper limit of normal; 5. Patients with myopathy or increased serum creatine kinase that cannot be explained by muscle damage (greater than 5 times the upper limit of normal); 6. Patients who are allergic to Xuezhikang or pravastatin, and take glucocorticoids or contraceptives for a long time; 7. In the acute stage of various infectious diseases, suffering from hyperthyroidism or hypothyroidism, acute cerebrovascular disease, severe heart or renal insufficiency ( > CKD3 stage), malignant tumor, hematopoietic system disease, autoimmune system disease, severe impact Patients with digestive or/and absorptive digestive diseases, mental diseases, severe or unstable physical diseases; 8. Abuse or dependence on alcohol or drugs in the past three months; 9. Patients who have participated in clinical trials of other drugs in the past three months; 10. The researcher believes that there are other situations that are not suitable for participating in the trial.

Design outcomes

Primary

MeasureTime frame
Fasting blood lipid routine;Fasting HbA1c% levels;Blood lipids complete set ;Blood lipid routine;Hypersensitive C-reactive protein(hs-CRP) ;Insulin levels;Plasma Glucose (PG) levels;Blood routine;Urine routine;

Secondary

MeasureTime frame
Creatine kinase;Hepatic function test;Renal function test;

Countries

China

Contacts

Public ContactLiu Ling

The Second Xiangya Hospital, Central South University

feliuling@csu.edu.cn+86 13723876466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026