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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

Cardiology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005280
Enrollment
Unknown
Registered
2021-09-05
Start date
2021-09-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

essential hypertension

Interventions

2:Pinggan Qianyang Formula
1:Pinggan Qianyang Formula placebo

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai , China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 15 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
24-hour ambulatory blood pressure;

Secondary

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

Countries

China

Contacts

Public ContactWang Xiaolong

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China(528 zhangheng Road, Pudong New Area, Shanghai)

wxlqy0214@163.com13501991450

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026