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A multicenter, randomized, double-blind, controlled clinical study for the synergistic optimal antihypertensive effect of Yangxue Qingnao Pill combined with amlodipine

A multicenter, randomized, double-blind, controlled clinical study for the synergistic optimal antihypertensive effect of Yangxue Qingnao Pill combined with amlodipine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022470
Enrollment
Unknown
Registered
2019-04-12
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Hypertension

Interventions

Experimental group:Yangxue Qingnao Pill + amlodipine

Sponsors

Department of Geriatric Cardiology, the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects must meet all of the following criteria in order to qualify for the group experiment: 1. Age range from 18 to 75 years, not limited to gender. 2.? has been diagnosed with hypertension patients after lifestyle intervention in three months, blood pressure levels in 140mmHg= systolic pressure <160Mmhg and/or 90mmHg= diastolic pressure <100 mmHg in hypertensive patients. ? the hypertensive patients who is regularly taking antihypertensive drugs now, the highest blood pressure does not exceed 160/100mmHg before medication, and willing to deactivate the current antihypertensive drugs for 2 weeks. 3. Chinese medical syndrome type is blood deficiency and hyperactivity of the liver. 4. Patients volunteered for the study and signed an informed consent statement.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this experiment: 1. Patients who are allergic to any ingredient in the study of drugs. 2. Patients with previous or existing clinical diagnoses of heart disease include acute coronary syndrome, stable coronary heart disease, postoperative revascularization, ischemic cardiomyopathy, congestive heart failure, etc. 3. Patients with previous or existing clinical diagnoses of cerebrovascular disease: ischemic stroke, cerebral hemorrhage, transient ischemic attack and so on. 4. Patients with previous or existing clinical diagnoses of kidney disease, including diabetic nephropathy, impaired renal function, eGFR<60ml/min/1.73m2. 5. Patients with previous or existing clinical diagnosed as peripheral vascular disease. 6. Patients with previous or existing clinical diagnoses of retinopathy, including bleeding or exudation, optic nipple edema, etc.. 7. Patients with previous or existing clinical diagnoses of diabetes, including fasting blood glucose =7.0mmol/L (126mg/dL) and after meal blood glucose or OGTT2h=11.1mmol/L (200mg/dL) or glycosylated hemoglobin = 6.5%. 8. Exclude secondary hypertension: Sleep apnea syndrome, primary aldosterone hyperplasia, renal artery stenosis, pheochromocytoma, cortisol hyperplasia, arterial disease, drug-induced hypertension, etc.. 9. Patients with severe liver disease (including the ALT or AST=2.5 times the upper limit of the normal value) or patients with biliary occlusion. 10. Poor blood pressure control after taking antihypertensive drugs (systolic pressure =160mmHg, and/or diastolic pressure =100mmHg). 11. Patients with pancreatic diseases. 12. Patients after total or subtotal gastrectomy, with short bowel syndrome and other restrictions on oral medicine absorption. 13. Diagnosis or suspected malignant neoplasms. 14. Suffering from serious diseases that may limit the efficacy evaluation or safety evaluation of this study. 15. Pregnant or lactating women and women who plan to conceive are unwilling or do not take adequate contraception. 16. The researchers judged patients who were not suitable for this study.

Design outcomes

Primary

MeasureTime frame
SBP and DBP;

Countries

China

Contacts

Public ContactLi Xiaoying
xyli301@163.com+86 13501230797

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026