hyperlipidemia
Conditions
Interventions
experimental group:Tiaozhi Tongluo Capsule (investigational product)
control group:Tiaozhi Tongluo Capsule-matching placebo
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male or female, aged 18–65 years. (2) Meet Western-medicine diagnostic criteria for hyperlipidemia AND, EITHER – have not taken any lipid-lowering drugs and have fasting LDL-C > 3.4 mmol/L (130 mg/dL), OR – have been on a stable, guideline-based regimen of statins, cholesterol-absorption inhibitors, probucol, bile-acid sequestrants, fibrates, niacin, high-purity fish-oil preparations, MTP inhibitors, apo-B100 synthesis inhibitors, PCSK9 inhibitors, or other Western lipid-lowering agents for = 4 weeks and still have fasting LDL-C > 3.4 mmol/L (130 mg/dL). (3) Meet Traditional Chinese medicine syndrome-differentiation criteria for hyperlipidemia (phlegm–blood stasis pattern). (4) Willing to participate, able to give written informed consent, and committed to complying with all trial requirements.
Exclusion criteria
Exclusion criteria: (1) Known malignancy, organ failure, post-transplant status, or any other serious chronic disease. (2) Uncontrolled hypertension (SBP = 180 mmHg and/or DBP = 110 mmHg), severe cardiac or pulmonary insufficiency, severe arrhythmias (e.g., rapid atrial fibrillation, complete bundle-branch block), or any serious disease in an acute phase. (3) Diagnosis of familial refractory hyperlipidemia. (4) Abnormal liver or renal function: ALT, AST, or total bilirubin > 1.5 × ULN; serum creatinine > 1.5 × ULN; CK > 1.5 × ULN; or severe impairment of hematopoietic or autoimmune systems. (5) Pregnant or lactating women, or women planning pregnancy within 3 months. (6) History of acute coronary syndrome, coronary revascularization, congestive heart failure (NYHA class > II), cerebrovascular accident (including TIA), severe peripheral atherosclerotic disease, cardiovascular or major surgery. (7) Severe psychiatric illness or significant speech/hearing impairment that would compromise compliance. (8) Inability to cooperate because of alcohol abuse, intellectual disability, or analogous reasons. (9) Long-term use of thyroid hormones, systemic steroids, or estrogen/progestogen preparations. (10) Known hypersensitivity to any component of the investigational product. (11) Participation in another clinical drug study within 1 month or current use of other Chinese herbal products. (12) Judgment by the investigator that the participant is unlikely to comply with trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| low-density lipoprotein cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| High-Density Lipoprotein Cholesterol;triglycerides;total cholesterol;Apolipoprotein B;Apolipoprotein E;Atherosclerosis Assessment;Carotid & Vertebral Duplex Ultrasound;Traditional Chinese Medicine (TCM) Syndrome Severity Scale; Lipoprotein (a); | — |
Countries
china
Contacts
Public Contactwangxinlu
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed