A randomized, placebo-controlled, double-blind trial of pinggan Qianyang Prescription in the treatment of hypertension with hyperactivity of Liver Yang to control the blood pressure of patients below the standard

Not Applicable

Recruiting

• Conditions: essential hypertension

• Registration Number: ITMCTR2100005280
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai , China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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-h ambulature of 130mmHg= diastolic blood pressure < 160mmHg and/or 90mmHg= diastolic blood pressure < 100mmHg after 3 months of lifestyle intervention with or without antihypertensive drugs. The standard of TCM disease differentiation and syndrome differentiation refers to the standard of liver-yang hyperactivity syndrome in guiding Principles for Clinical Research of New Chinese Medicine and Guiding Principles for Clinical Diagnosis and Treatment of Hypertension. Main symptoms: ? dizziness; (2) a headache; Secondary symptoms: ? irritable; (2) mouth bitter; ? Insomnia,; Lumbar acid (4); ? Pulse string number or inch pulse alone flourishing; ? Pulse string length, straight inch mouth. One of the main disease necessary, and see the second disease two.

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 < 60mL /min/1.73m2;
(6) Secondary hypertension: sleep apnea syndrome, pheochromocytoma, renal artery stenosis, primary aldosteronism, cortisolism, large artery disease, drug-induced hypertension, etc.;
(7) Patients with severe liver disease (including ALT or AST=2.5 times the upper limit of normal value) 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

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour ambulatory blood pressure;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome integral;endothelial function;Self-test blood pressure at home;SOD\hs-CRP;cellular immunity;PWV+ABI;UCG;