About 179 million people die from cardiovascular disease each year, accounting for approximately 31% of global deaths. It is expected that this number will exceed 236 million by 2030, and the economic burden caused by this disease is increasing year by year.At present, the number of people suffering from cardiovascular diseases in China is as high as 330 million, and the mortality rate accounts for more than 40% of the total deaths caused by diseases, and is in a continuous upward trend.Long term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseases.Tibetan tea contains catechins, caffeine, amino acids, vitamins, and various mineral components, which have significant effects in reducing cholesterol, improving carbohydrate metabolism, lowering blood sugar, losing weight, softening human blood vessels, and other aspects.At present, there are no research reports on the lipid-lowering effect of Mongolian Gongzi Tibetan Tea Special Drink, and most studies on the lipid-lowering effect of Tibetan Tea are animal experiments or clinical observational studies. Therefore, this study intends to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Mongolian Gongzi Tibetan Tea Special Drink in patients with hyperlipidemia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Meets the diagnostic criteria for hyperlipidemia: total cholesterol (TC) ≥ 6.20mmol/L, triglycerides (TG) ≥ 2.30 mmol/L. If one of the above blood lipid indicators is abnormal, it can be included in this study;
2. Age ≥ 18 years old, gender not limited;
3. The patient is willing to follow the research protocol and sign an informed consent form.
Exclusion Criteria:
1. Atherosclerotic cardiovascular disease (ASCVD) patients;
2. Diabetes patients;
3. Severe hypercholesterolemia (TC\>8 mmol/L or LDL-C ≥ 4.9 mmol/L) or severe hypertriglyceridemia (TG ≥ 5.6 mmol/L);
4. Secondary hyperlipidemia;
5. Individuals with a family history of primary hypercholesterolemia;
6. Active liver disease or unexplained persistent elevation of serum transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2-fold upper limit of normal (ULN));
7. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2;
8. Creatine kinase (CK)\>3 times ULN;
9. Individuals who have used any lipid-lowering drugs within the past month; 10）Individuals allergic to Tibetan tea and atorvastatin calcium;
11\) Individuals with combined mental illnesses or malignant tumors; 12) Pregnant and lactating women; 13) Researchers consider patients who are not suitable for inclusion in the study.
Primary outcome measure(s)
TC — 4 weeks Comparison of TC levels between Tibetan tea and a simple low-fat diet compared to baseline
TG — 4 weeks Comparison of TG levels between Tibetan tea and atorvastatin compared to baseline
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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