High TMAO level
Conditions
Interventions
Test group:Taking Duzhong Wuzhen Tablets
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years, regardless of gender. 2. Plasma TMAO >= 381.2 ng/mL (based on the reference value provided in the TMAO assay kit). 3. Possess the ability to understand the nature of the study, voluntarily sign the informed consent form, and agree to strictly comply with the requirements of the clinical trial to complete the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with current severe infections (sepsis, central nervous system infection, tuberculosis, viral pneumonia), malignant tumors (including solid tumors, hematological malignancies, receiving chemotherapy/radiotherapy/immunotherapy, metastatic tumors), acute renal failure, uremia, or acute cardiovascular and cerebrovascular diseases (including acute coronary syndrome, acute myocardial infarction, aortic dissection, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack). 2. Subjects with abnormal liver function, where ALT and AST levels are >3 times the upper limit of normal. 3. Subjects who have used antihypertensive drugs, lipid-lowering drugs, or hypoglycemic drugs with unstable dosages for less than 2 weeks prior to the screening period, or who cannot maintain their original dosage during the study period. 4. Subjects who have used antibiotics or probiotic preparations within the past 1 month. 5. Subjects who have undergone major surgery within the past 1 month. 6. Subjects who have undergone lower gastrointestinal examination via enema within the past 1 month, or who have severe gastrointestinal diseases. 7. Pregnant women, women planning to become pregnant, or lactating women. 8. Subjects with allergy or intolerance to the active ingredients or excipients of the study product. 9. Subjects with any other conditions that, in the investigator’s judgment, may prevent them from completing the study or expose them to significant risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trimethylamine N-Oxide (TMAO); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood lipids;Blood glucose;Blood pressure;Creatinine;Blood Urea Nitrogen;Uric Acid;IL-6;TNF-a; | — |
Countries
China
Contacts
Public ContactYang Pingting
The Third Xiangya Hospital, Central South University
Outcome results
None listed