Primary hyperlipidemia
Conditions
Interventions
High dose group:9g/d Yinlan Tiaozhi Capsule
Medium dose group:6g/d Yinlan Tiaozhi Capsule
Low dose group:3g/d Yinlan Tiaozhi Capsule
Placebo group:Yinlan Tiaozhi Capsule placebo
Sponsors
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. TCM syndrome differentiation is phlegm and stasis syndrome; 3. The induction period meets the diagnostic criteria of primary hyperlipidemia Western medicine, and 3.4 mmol/L (130 mg/dl) = LDL-C<4.9 mmol/L (190 mg/dl); 4. During the introduction period, a 4-week TLC intervention (maintaining a balanced diet and lifestyle habits, and discontinuing all drugs that affect blood lipids, see Appendix I), the fasting blood lipids after the end of the introduction period still meet the above diagnostic criteria; And the difference between the introduction period and the baseline two low-density lipoprotein cholesterol (LDL-C) is not more than 12% (according to the higher value); 5. The baseline dietary score = 5 points; 6. Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute myocardial infarction, cerebrovascular accident, severe trauma or major surgery within six months; 2. Hyperlipidemia caused by other diseases, such as nephrotic syndrome, hypothyroidism, gout, severe hepatobiliary disease (viral hepatitis, cholecystitis, cholelithiasis), etc. Hypertension; known hyperlipidemia caused by drugs (phenothiazines, beta blockers, adrenal corticosteroids, certain contraceptives, etc.) and known pure A zygote type of hypercholesterolemia; 3. Patients who are taking hormones, thyroxine treatments and other drugs that affect blood lipid metabolism, and patients who have used other lipid-lowering measures in the past two weeks; 4. Patients who underwent PCI and CABG within one and a half years, who had acute coronary syndrome within six months, and those with grade III or higher cardiac function; 5. Allergic or allergic to known pharmaceutical ingredients; 6. Patients who have not been controlled by systemic antihypertensive therapy for blood pressure (>180/110 mmHg); 7. Patients with triglyceride (TG) = 5.7 mmol / L (500 mg / dl); 8. The daily smoking amount is more than 5 in the first 3 months of screening, or the daily smoking amount is more than 5 in the test period; 9. Those with abnormal liver and kidney function (ALT and / or AST = 1.5 times the upper limit of normal value, Scr > upper limit of normal value) and those with severe hematopoietic diseases; 10. Patients (including male spouses) have pregnancy planning, pregnancy or lactation women during the trial period and within 6 months after the last dose; 11. Patients requiring long-term anticoagulant therapy and adrenal corticosteroids; 12. Type 1 diabetes, type 2 diabetes (systemic hypoglycemic treatment, after the introduction period, random blood glucose = 11.0mmol / L, glycosylated hemoglobin = 9% patients); 13. Patients with malignant tumors, chronic alcoholism, drug dependence or mental illness; 14. Those who have participated in or are participating in other clinical trials within the past 3 months; 15. The investigator believes that it is not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week LDL-C relative baseline change; | — |
Secondary
| Measure | Time frame |
|---|---|
| 4 weeks LDL-C relative baseline change;8 weeks LDL-C relative baseline change;TC relative baseline change (one dose for 4, 8, and 12 weeks);TG relative baseline change (one dose for 4, 8 and 12 weeks);HDL-C relative baseline change (one dose for 4, 8, and 12 weeks);Non-HDL-C relative baseline change (one dose for 4, 8, and 12 weeks);TCM syndrome efficacy (use once every 4, 8 and 12 weeks);Efficacy of single symptom in TCM (one dose for 4, 8 and 12 weeks); | — |
Countries
China
Contacts
Public ContactLiu Hongxu
Outcome results
None listed