Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study the effects of Menggongzi Tibetan Tea Special Drink in lowering cholesterol levels in people with high blood lipids, a condition known as hyperlipidemia. High cholesterol can increase the risk of heart disease, which is a major health issue worldwide. The researchers want to see if this special Tibetan tea can help improve cholesterol levels safely and effectively.

To participate in this study, you need to be at least 18 years old and have high cholesterol or triglyceride levels. However, people with certain conditions, like heart disease, diabetes, or severe forms of high cholesterol, will not be eligible. If you choose to take part, you'll follow a specific plan and provide informed consent, which means you agree to participate after understanding the study. This trial is not yet recruiting participants, but it aims to provide valuable information about a natural approach to managing cholesterol levels.

Gender

ALL

Eligibility criteria

• 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.