Untreated hyperlipidemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chinese adults aged =18 and =65 on the date of signing the informed consent, regardless of gender; 2. Fasting 5.2 mmol/L < serum total cholesterol (TC) < 7.2 mmol/L and/or 1.7 mmol/L < serum triglyceride (TG) < 5.6 mmol/L and/or 3.4 mmol/L < low density lipoprotein cholesterol (LDL-C) < 4.9 Patients with mmol/L and/or high-density lipoprotein cholesterol (HDL-C) < 1.0 mmol/L; 3. Understand the research procedures and methods, participate in this experiment voluntarily, and sign informed consent in person.
Exclusion criteria
Exclusion criteria: 1.Patients with diseases of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, nervous/psychiatric system, blood and lymphatic system, skeletal muscle system, and so on. Patients with diseases of chronic gastritis and gastric ulcer, who are taking alkaline drugs such as sodium bicarbonate and magnesium oxide that are not suitable for drinking acidic solutions; 2.Patients diagnosed with nephrotic syndrome, severe liver disease, Cushing's syndrome, thyroid insufficiency and other diseases that significantly affecting serum of lipid levels; 3.Patients with infectious diseases in the active stage that are not suitable for participating in the clinical trial according to the evaluating of researcher; 4.Patients are diagnosed with malignant tumors within 5 years before screening (excluding the cured malignant tumors that have not observed recurrence in the last 5 years, completely resected basal and squamous cell skin cancers, and carcinoma in situ); 5.Subjects participated in other clinical trials of drug interventions within 2 weeks before screening (excluding subjects screening fail); 6.Subjects with history of drug abuse before screening; 7.Subjects with history of major surgery within 3 months before screening or planning major surgery during the study; 8.Subjects with history of long-term (=7 days) and (or) repeated (cumulative use of =3 times) systemic use of glucocorticoids, hypoglycemic drugs (including but not limited to biguanides, alpha-glucosidase inhibitors, glucagon-like peptide-1 receptor agonists, etc.), antihypertensive drugs (including but not limited to ß-receptor blockers, thiazide diuretics, etc.), antibiotics (including but not limited to anti-tuberculosis drugs, antibacterial drugs, etc.) and antitumor drugs within 3 months before screening (excluding local use, such as intra-articular, nasal, inhalation, skin external use, and etc.); 9.Subjects with history of using weight-loss drugs or surgery that caused to weight instability within 2 months before screening; 10.Subjects with history of using lipid-lowering drugs (including but not limited to statins, bates, cholesterol absorption inhibitors, niacin) or health products with lipid-lowering effects within 4 weeks before screening; 11.Subjects are allergic to any ingredient in Roxburghii and Roxburghii yeast active stock; 12.Subjects with positive test results of hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), treponema pallidum antibody (TP-Ab); 13.Male or female subjects does not consent to use effective contraception during the clinical trial; 14.Subjects are pregnant or lactating women; 15.Subjects are not suitable for this clinical study according to the investigator evaluating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cholesterol;Triglyceride;HDL-C; | — |
Secondary
| Measure | Time frame |
|---|---|
| LDL-C;Lp(a);LDL/HDL; | — |
Countries
China
Contacts
The Affiliated Hospital of Guizhou Medical University