Hypertension associated with the metabolic syndrome
Conditions
Interventions
Treatment group:Basic treatment (Irbesartan 150mg each time, once a day) + Bai'ai capsules (0.5g each tablet) 3 tablets each time, 2 times a day, taking pills in the morning and 0.5-1 hours after dinn
placebo control group:Basic treatment (Irbesartan 150mg each time, once a day) + placebo (0.5g each tablet) 3 tablets each time, 2 times a day, taking pills in the morning and 0.5-1 hours after dinner
Sponsors
Affiliated Huashan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for metabolic syndrome; 2. BP 130/85 to 160/100mmHg, or a medical history of hypertension; 3. Men and Women, 18 to 75 Years of Age; 4. Informed consent and signed voluntarily; 5. blood TG=1.70mmol/L(150mg/dl)or blood HDL-c<1.04mmol/L (40mg/dl); 6. FPG 6.1 mmol/L to 7.0 mmol/Land/or PPG 7.8mmol/L to 11.1 mmol/L or a medical history of diabetes; 7. TCMthere should be at least one syndrome including YureYuxueTangshi on the basis of Pixu Buhua.PSeither 5 or 6 will be fine.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, or plan to pregnant, or nursing mothers; 2. Secondary hypertension; 3. with psychosis; 4. allergic constitution, or allergy to a variety of drugs; 5. had received other clinical experiment for new drug in the late three months; 6. the clinical manifestations of merging the organic damage, such as: heart: angina pectoris, myocardial infarction, heart failure. Brain: transient ischemic attack (TIA), stroke, hypertension encephalopathy.Fundusretinal hemorrhage, exudate with or without apparent papillary edema.Kidney: serum creatinine greater than 144 mmol/L, kidney failure. Blood vessels: Artery dissection, artery occlusive disease. 7. recent intense volatility in blood pressure; 8. other serious internal diseases.(such as: serious respiratory disease, rheumatoid disease, tumor, etc.); 9. liver or kidney impairment.(ALT=3 or more times the upper limit of normal value and/or a AST=3 or more times the upper limit of normal, Cr > upper limit of normal); 10. can't understand the informed consent and visit on time; 11. fasting blood sugar > 10 mmol/L or TG > 5 mmol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure;24-hour ambulatory blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| The main symptoms and signs;blood lipids;fasting plasma glucose (FPG);2h postprandial plasma glucose (PPG);fasting insulin;Glycated hemoglobin;body mass index;Waistline;waist-to-hip ratio;TCM syndrome score;exit rate of poor efficacy; | — |
Countries
China
Contacts
Public ContactXiaoDong Fu
Affiliated Huashan Hospital of Fudan University
Outcome results
None listed