Essential hypertension
Conditions
Interventions
Pinggan Qianyang Formula group:Pinggan Qianyang Formula
Control group:Placebo
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Hypertension (the diagnostic criteria for hypertension were formulated according to the guidelines for the Prevention, Detection, Evaluation and Management of Hypertension in Adults in the United States 2017: hypertensive patients with a 24-hour ambulature of 130 mmHg < diastolic blood pressure < 160 mmHg and/or 90 mmHg <= diastolic blood pressure < 100 mmHg after 3 months of lifestyle intervention with or without antihypertensive drugs; 2. TCM syndrome differentiation is the syndrome of hyperactivity of liver-yang, and the standard refers to Guidelines for Clinical Research of New Chinese Medicines and Guidelines for Clinical Diagnosis and Treatment of Hypertension in Traditional Chinese Medicine: (1) Main symptoms: 1) dizziness; 2) a headache; (2) Secondary symptoms: 1) irritable; 2) mouth bitter; 3) insomnia,; 4) lumbar acid; 5) pulse string number or inch pulse alone flourishing; 6) pulse string length, straight inch mouth; One of the main disease necessary, and including the second disease two.
Exclusion criteria
Exclusion criteria: 1. Allergic to any ingredient in the study drug; 2. With serious or poorly controlled diseases, such as heart failure, congenital heart disease, rheumatic heart disease, serious arrhythmias or arrhythmias leading to inaccurate blood pressure measurement (such as atrial fibrillation), etc.; 3. Patients with new myocardial infarction or recurrent unstable angina pectoris (usually within 12 weeks); 4. Newly diagnosed cerebrovascular diseases within 6 months before inclusion; 5. Patients with previous or existing diagnosed kidney disease, including diabetic nephropathy, impaired renal function, eGFR = 2.5 x ULN) or biliary tract occlusion; 8. Patients with total gastrectomy, subtotal gastrectomy and limited oral drug absorption diseases such as short bowel syndrome; 9. Associated diseases such as autoimmune diseases, acute inflammation, tumors, peripheral vascular diseases, lower limb venous thrombosis and other diseases that may affect the results of this study; 10. Combination of cognitive and emotional disorders can not effectively cooperate; 11. Women who are pregnant or breast-feeding and who plan to become pregnant are unwilling or do not take adequate contraceptive measures; 12. Patients determined by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour ambulatory blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-test blood pressure at home;Pulse wave velocity(PWV) and ankle brachial index(ABI);UltrasoundCardiogram;Traditional Chinese Medicine syndrome integral;Cellular immunity(IL-6, IL-10, TNF-alpha, TGF-beta);Endothelial function(ET-1);hs-CRP(hypersensitive-c-reactive-protein);Superoxide dismutase(SOD); | — |
Countries
China
Contacts
Public ContactWang Xiaolong
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed