Hypertension
Conditions
Interventions
Experimental Group:Qianyang Yuyin Granules 20g bid + Valsartan Amlodipine 80/5mg qd
Control Group:Qianyang Yuyin Granules placebo 20g bid + Val 80/5mg qd
Sponsors
Jiangsu Provincial Traditional Chinese Medicine Hospital GCP Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Primary Stage 2 and 3 hypertension; 2. Meets the diagnostic criteria for the TCM pattern of yin deficiency and yang hyperactivity; 3. On amlodipine-based antihypertensive therapy with blood pressure controlled to target levels (referencing the 2024 Chinese Hypertension Prevention and Treatment Guidelines: systolic blood pressure (SBP) 6 m/s, systolic end (ES) >7 m/s; 5. Age between 18-65 years; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with a history of severe life-threatening diseases, such as acute myocardial infarction, acute stroke, heart failure with Class IV functional impairment, malignant arrhythmias, or mid-to-late stage malignant tumors; 2. Individuals with changes in carotid artery morphology, such as carotid intima-media thickness (cIMT) >1.2mm; 3. Patients with diabetes; 4. Patients with hyperlipidemia who have poor lipid control (low-density lipoprotein >3.4mmol/L); 5. Patients with contraindications to the use of CCB, ACEI, or ARB medications; 6. Liver function (AST or ALT) greater than twice the upper limit of normal; renal function (Scr) greater than the upper limit of normal; 7. Patients with a history of mental illness or legal disability; 8. Those currently pregnant or breastfeeding; 9. Individuals who have participated in other interventional clinical studies within the past month; 10. Other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic left and right carotid artery PWV (pulse wave velocity) - BS (baseline) change rate.;Systolic left and right carotid artery PWV-ES change rate;The change rate of PWV-BS in the left and right carotid arteries during diastole.;The change rate of flow-mediated vasodilation (FMD) in the right brachial artery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) showed an average change rate compared to baseline.;The blood pressure achievement rate after administration in the two groups.;The rate of change in arterial vascular function among two groups of different age ranges (18-40 years old, 40-65 years old).;The improvement rate of Chinese medicine symptom scores after administration in two groups.;The improvement rate of individual symptom scores after administration in two groups;Carotid Intima-Media Thickness (C-IMT) Change Rate;Blood Nitric Oxide Analysis (NO), Homocysteine (HCY) Change Rate; | — |
Countries
China
Contacts
Public ContactZou Chong
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed