Status:
NOT_YET_RECRUITING
Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Every year, approximately 179 million people die from cardiovascular diseases, accounting for about 31% of global deaths. This number is expected to exceed 236 million by 2030, and the economic burden...
Eligibility Criteria
Inclusion
- 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;
- Age ≥ 18 years old, gender not limited;
- The patient is willing to follow the research protocol and sign an informed consent form.
Exclusion
- Atherosclerotic cardiovascular disease (ASCVD) patients;
- Diabetes patients;
- Severe hypercholesterolemia (TC\>8 mmol/L or LDL-C ≥ 4.9 mmol/L) or severe hypertriglyceridemia (TG ≥ 5.6 mmol/L);
- Secondary hyperlipidemia;
- Individuals with a family history of primary hypercholesterolemia;
- Active liver disease or unexplained persistent elevation of serum transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2-fold upper limit of normal (ULN));
- The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2;
- Creatine kinase (CK)\>3 times ULN;
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 8 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT06551298
Start Date
October 1 2024
End Date
August 8 2025
Last Update
September 25 2024
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000