Hyperlipidemia
Conditions
Interventions
Control group:FTZ simulant, 4 capsules (2.52 g) each time, 3 times a day.
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 3.4mmol/L (130mg/dl) =Fasting LDL-C=4.9mmol/L (190mg/dl). 2. BMI 18 to 36kg/m2. 3. Aged 18 to 65 years, male and female; 4. Agree to participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. TG>5mmol/L (440mg/dl); 2. Within 6 months prior to screening visits, patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major surgery; 3. Patients with poor hypertension control during screening visits (office systolic blood pressure >= 180mmHg, diastolic blood pressure >= 110mmHg); 4. HbA1c>7.0% of diabetic patients; 5. Combined with severe liver and kidney disease, or abnormal liver and kidney function tests (ALT, AST >=3 times normal upper limit, urea nitrogen (BUN) or creatinine (Scr) > normal upper limit; 6. Those suffering from endocrine diseases affecting blood lipids or lipoproteins (such as hypothyroidism, nephrotic syndrome, etc.); 7. Patients with active malignant tumors, heart failure, and respiratory failure; 8. Those who have neurological or mental illnesses who are unable to cooperate or are unwilling to cooperate; 9. Those who have a history of alcohol or anesthesia abuse within 2 years prior to screening visits; 10. Pregnant or lactating patients; 11. Take lipid-lowering drugs or drugs that may affect blood lipid levels (such as hormones, birth control pills, thiazide diuretics, etc.) within 4 weeks prior to screening visits;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with LDL-C levels <130 mg/dl (3.4 mmol/L) or <100 mg/dl (2.6 mmol/L) at Week 12 (or last visit);; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average percentage change of TC, TG, Non-HDL-C levels relative to baseline at Week 12 (or last visit);;Chinese medicine symptoms Score;TCM Syndrome Score;Adverse reaction/incident rate; | — |
Countries
China
Contacts
Public ContactGuo Jiao
the First Affiliated Hospital of Guangdong Pharmaceutical University
Outcome results
None listed