A randomized, double-blind, dose-exploratory, placebo parallel-controlled, multicenter phase II clinical trial to evaluate the safety and efficacy of Mang-Ji-Shi capsule in the treatment of primary hyperlipidemia
- Conditions
- Primary hyperlipidemia
- Registration Number
- ITMCTR2000003563
- Lead Sponsor
- Beijing Chinese Medicine Hospital affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria of primary hyperlipidemia;
2. (LDL-C)>= 3.4 mmol/L (130mg/dl)during the introduction and baseline periods,and the difference value of LDL-D between introduction and baseline is no more than 12% (be subject to whichever is higher);
3. TCM syndrome differentiation is phlegm and stasis syndrome;
4. Aged 18 to 75 years (contains 18 and 65), unisex;
5. Voluntary signing of informed consent.
1. Hyperlipidemia caused by other diseases, such as nephrotic syndrome, hypothyroidism, gout, severe hepatobiliary disease anddiabetes mellitus. Hypertension; known hyperlipidemia caused by drugs (phenothiazines, beta blockers, adrenal corticosteroids, certain contraceptives, etc.) and known pure A zygote type of hypercholesterolemia;
2. Patients with triglyceride (TG) >= 5.7mmol/L;
3. Patients who are taking hormones, thyroxine treatments and other drugs that affect blood lipid metabolism;
4. Patients with acute myocardial infarction, cerebrovascular accident, severe trauma,PCI or other major surgery within six months that taking lipid-lowering for long-term medication;
5. Patients with acute coronary syndrome; and with heart failure,NYHA rate >= III; with severe arrhythmia (like Frequent ventricular premature, ventricular tachycardia,rapid atrial fibrillation and others) or other liver, kidney, endocrine, hematopoietic system and other serious diseases.
6. Patients with uncontrolled hypertension (Sitting diastolic pressure >= 110 mmHg or systolic pressure >= 180 mmHg), or taking hypotensive drugs (Diuretics, beta blockers);
7. Type 1 diabetes, type 2 diabetes(HbA1c >= 8.5%);
8. 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;
9. Allergic or allergic to mangosteen or this drug ingredient;
10. Patients have pregnancy planning, pregnancy or lactation women during the trial period;
11. Patients with A history of malignancy or related disease;
12. Patients with A history of mental illness, substance abuse, or alcohol dependence;
13. Those who have participated in or are participating in other clinical trials within the past 3 months;
14. The investigator believes that it is not suitable for clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of change of LDL-C from baseline after 12 weeks of treatment;
- Secondary Outcome Measures
Name Time Method rate of change of TC from baseline after 4 weeks, 8 weeks and 12weeks of treatment;rate of change of TG from baseline after 4 weeks, 8 weeks and 12weeks of treatment;rate of change of LDL-C from baseline after 4 weeks and 8 weeks of treatment;Curative effect of TCM syndromes after 4 weeks, 8 weeks and 12weeks of treatment;Curative effect of TCM single symptom after 4 weeks, 8 weeks and 12weeks of treatment;rate of change of HDL-C from baseline after 4 weeks, 8 weeks and 12weeks of treatment;