Primary hypertension grades 2-3 in middle-aged and young adults with combined dyslipidemia
Conditions
Interventions
Research group:Use one or more conventional antihypertensive drugs in combination with Songling Xuemaikang capsules (3 capsules per dose, oral, 3 times a day).
control group:Use one or more conventional antihypertensive drugs, with the same selection of conventional antihypertensive drugs as the study group.
Sponsors
Shaanxi Provincial Transportation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 65 years old, regardless of gender; (2) Diagnosed as a patient with primary hypertension (grade 2 or 3 primary hypertension, sitting diastolic blood pressure = 100mmHg, or systolic blood pressure = 160mmHg), with initial or previous diagnosis but poor blood pressure control (sitting diastolic blood pressure>90mmHg, with or without systolic blood pressure>140mmHg): The diagnostic criteria for hypertension can be found in the 2018 revised edition of the Chinese Guidelines for the Prevention and Treatment of Hypertension; Before measuring blood pressure, the subject should rest quietly for at least 5 minutes, and repeat the measurement every 1-2 minutes. The average recorded value of the two readings should be taken. If the difference in systolic and/or diastolic blood pressure readings between the two readings is more than 5mm Hg, it should be measured again and the average of the three readings should be taken; (3) Patients who meet the diagnostic criteria for dyslipidemia (according to the 2016 revised Chinese Guidelines for the Prevention and Treatment of Adult Hyperlipidemia): total cholesterol = 6.2mmol/L, and/or triglycerides = 1.7mmol/L, and/or LDL-C = 4.1mmol/L, and/or HDL-C<1mmol/L on an empty stomach. (4) Agree to receive education and adhere to a regular lifestyle intervention during the experimental process; (5) Voluntarily accept treatment with this medication and sign an informed consent form. The informed consent process complies with the relevant provisions of GCP.
Exclusion criteria
Exclusion criteria: (1) Diagnosed as a patient with primary mild hypertension (grade 1 primary hypertension), or with grade 2-3 hypertension (diastolic blood pressure10mmol/L; (4) Patients with a history of heart disease related to: 1) angina; 2) myocardial infarction occurring within 6 months prior to obtaining informed consent; 3) coronary artery revascularization surgery performed within 6 months prior to obtaining informed consent; 4) heart failure (NYHA heart function grade II and above); 5) severe arrhythmia including atrial fibrillation, atrioventricular block (grade II and III), sinoatrial block, and sick sinus syndrome; (5) Patients with severe primary diseases such as liver, kidney, and hematopoietic system, or serious diseases that affect their survival (such as tumors) and psychiatric patients; (6) A history of significant organ bleeding in the past six months (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), decreased platelet count, abnormal coagulation function, recent active bleeding, etc; (7) Clinically significant laboratory test abnormalities, including but not limited to: blood potassium>5.5mmoL/L; Blood ALT and/or AST>2.5 x upper limit of normal value (ULN); Blood creatinine>1.5 x ULN; Any clinically significant laboratory abnormalities that the researchers believe may interfere with the efficacy and/or safety evaluation of this study; (8) Using lipid-lowering drugs within the past month, including but not limited to statins, beta, cholesterol absorption inhibitors, PCSK9 inhibitors, niacin, and high-purity fish oil preparations; Use sleep improving drugs within the past 2 weeks, including but not limited to benzodiazepines, non benzodiazepines, melatonin receptor agonists, appetite receptor antagonists, and antidepressants with hypnotic effects. (9) Patients who are known to be allergic to the investigational drug (including its ingredients); (10) Pregnant or preparing pregnant or lactating women; (11) Participate in other clinical studies within the past month; (12) Researchers believe that it is not suitable for participants in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The compliance rate of blood pressure- lipid composite indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in systolic blood pressure from baseline;Changes in diastolic blood pressure from baseline;Systolic blood pressure in dynamic blood pressure monitoring;Changes in fasting TC from baseline;Changes in fasting TG from baseline;Changes in fasting LDL-C from baseline;Changes in fasting HDL-C from baseline;Changes in fasting lipoprotein (a) compared to baseline;Changes in Fasting Apolipoprotein E from Baseline;Changes in Fasting Apolipoprotein B from Baseline;Changes in Fasting Apolipoprotein A1 from Baseline;Changes in C-reactive protein from baseline;TNF- a Changes from baseline;Changes in erythrocyte sedimentation rate from baseline;TNF- ? Changes from baseline;IL-1 ß Changes from baseline;Changes in IL-6 from baseline;Changes in Pittsburgh Sleep Quality Index;The incidence and severity of adverse events (AE); | — |
Countries
China
Contacts
Public ContactZhang Hengqiang
Shaanxi Provincial Transportation Hospital
Outcome results
None listed