A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome
- Conditions
- Essential Hypertension
- Registration Number
- ITMCTR2000003098
- Lead Sponsor
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Aged between 18-75 years old;
2. Patients who meet the western diagnostic standard of grade 2 hypertension and the TCM syndrome differentiation standard of hyperactivity of liver Yang syndrome;
3. The patients with grade 2 essential hypertension and moderate risk are identified according to the blood pressure level and cardiovascular risk stratification of hypertension, whose blood pressure meet any one of the following three criteria:
(1) Systolic blood pressure 160-179mmHg and/or diastolic blood pressure 100-109 mmHg, no previous use of any antihypertensive drugs, no complications such as heart, brain and kidney;
(2) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy, maintaining the blood pressure at 160-179/100-109mmhg;
(3) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy and oral antihypertensive medication, maintaining the blood pressure at 160-179/100-109mmhg;
4. Patients whose course of hypertension must be more than 3 months;
5. Patients with informed consent and signing informed consent.
1. With various secondary hypertension;
2. Patients Received other new drugs in the past 3 months;
3. Patients with moderate or severe diabetes or patients with myocardial infarction or cerebral apoplexy within half a year;
4. Pregnant or pregnant women and women in lactation;
5. Patients who are allergic to a variety of drugs or allergic constitution;
6. Patients with mental illness, alcoholism and/or psychoactive substance abuse and dependence;
7. With combining with the following organ damage or disease, angina pectoris, heart failure, transient brain, hypertensive encephalopathy, retinopathy (with or without apparent papillary edema), plasma creatinine concentration of 2.0 mg/dl or more renal function failure, liver failure, or aortic aneurysm, aortic dissecting aneurysm artery occlusive disease symptoms.
8. At present, patients who have taken valsartan 80mg/amlodipine 5mg and other ARB/CCB compound drugs, and whose blood pressure is still level 2 and above.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood fat;Urinary microalbumin;Blood pressure;Blood sugar;Homocysteine(HCY);Hypersensitive c-reactive protein;Syndrome score of TCM;Uric acid;
- Secondary Outcome Measures
Name Time Method