Metabolic Syndrome
Conditions
Interventions
Experimental group :It is forbidden to add all the Chinese and Western medicines with the same efficacy as the test drugs and the drugs that affect the safety evaluation of the drug during the study.
Control group :It is forbidden to add all the Chinese and Western medicines with the same efficacy as the test drugs and the drugs that affect the safety evaluation of the drug during the study.
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 20 to 70 years old; 2. Clinically diagnosed as metabolic syndrome (Refer to joint statements (2009) issued by the international diabetes federation (IDF) and organizations such as the American heart association and the American heart, lung and blood institute (AHA/NHLBI)); 3. Waist circumference Chinese men>=90cm, women >=85cm; 4. Meet the diagnostic criteria of TCM syndrome type; 5. BMI 24 to 33 kg/m2; 6. HbA1C <8.0%; 7. FEG 6.1 to 7.8 mmol/L; 8. LDL-c 3.12 to 4.9 mmol/L; 9. TC 5.72 to 8 mmol/L; 10. TG 1.7 to 5.6 mmol/L; 11. Subjects who are able to understand and are willing to sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. History of hypertension (defined as systolic BP >=150 mmHg, diastolic BP >=95 mmHg) or on anti-hypertension treatment (please note: if the subjects are on anti-hypertension medication at stable dose for over 3 months and no plan to change the drug regimen within next 3 months, they will not be excluded from this study); 2. Active use of coumadin, history of bleeding disorder, or abnormal clotting time (prothrombin time >14.6 seconds and activated partial thromboplastin time (aPTT) > 37.0); 3. History of diabetes (type 1 and type 2) and or other types of diabetes; 4. History of or active alcohol or drug abuse; 5. Human immunodeficiency virus (HIV) positive,Viral hepatitis (b,c); 6. Surgery within the previous 30 days; 7. Chronic renal insufficiency (Glomerular filtration rate (EGFR) 2.5x Upper limits of normal (ULN)), congestive heart (New York Heart Association (NYHA) Class III or IV); 8. Serious active infection, malignancy or chronic inflammatory disease; 9. Patients on statin therapy, including traditional Chinese medicine, chemical drugs, biological agents, health products, etc.; 10. Acute coronary syndrome or stroke or severe occlusion of lower limb vessels within 3 months prior to study; 11. Patients participate in any clinical investigational study within 3 months prior to screening; 12. Known allergy to investigational drug or any ingredients of the investigational drug, allergy to statins. 13. Pregnancy, lactation or women who are preparing for pregnancy or women of child-bearing potential who are unwilling to use appropriate medically approved contraception whilst receiving treatment; 14. Men whose partners are of child-bearing potential but who are not willing to use appropriate medically approved contraception whilst receiving treatment; 15. Inability to follow the protocol or comply with the study requirements; 16. Any other condition that, in the opinion of the investigator, might not be appropriate to be entered into this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Metabolic Syndrome; | — |
Countries
China
Contacts
Public ContactYue Changlin
Jiangsu Jiuxu Pharmaceutical Co., Ltd
Outcome results
None listed