Last updated: July 7, 2022
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Metabolic Syndrome
High Cholesterol (Hyperlipidemia)
Diabetes Prevention
Treatment
N/AClinical Study ID
NCT05118698
XJTU1AF2021LSK-273
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Low-density lipoprotein (LDL) cholesterol ≥130 mg/dL (3.4 mmol/L ), or conforms to thediagnosis criteria for metabolic syndrome (based on the MetS diagnostic criteriadeveloped by IDF and AHA in 2009), that is, having three or more of the followingtraits:
- waist circumference ≥90 cm in men or ≥80 cm in women;
- Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
- Reduced HDL-c (drug treatment for reduced HDL-c is an alternate indicator) < 40mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females;
- Elevated blood pressure (anti-hypertensive drug treatment in a patient with ahistory of hypertension is an alternate indicator). Systolic ≥ 130 and/ordiastolic ≥ 85 mmHg;
- Elevated fasting glucose (drug treatment for elevated glucose is an alternateindicator) ≥ 100 mg/dL (5.6 mmol/L).
- Be over 18 years old or younger than 80 years old, no gender limit.
- Have a good follow-up compliance and can be followed up for more than 3 months;
- From 2 weeks before enrollment to the end of the entire trial, the treatment regimenwill not change.
Exclusion
Exclusion Criteria:
- Pregnant and lactating women;
- Allergic or toxic reactions to gynostemma and other drugs;
- Infectious diseases such as viral hepatitis, AIDS, syphilis, tuberculosis are active;
- After drug treatment, still showing high blood sugar (fasting blood glucose higherthan 200mg/dL, 11.1mmol/L) or hyperlipidemia, or hypertension (higher than 180/110mmHg);
- Any conditions judged by the investigator that affect enrollment.
Study Design
Total Participants: 150
Study Start date:
March 01, 2022
Estimated Completion Date:
March 01, 2023
Connect with a study center
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
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