Grade 1 hypertension
Conditions
Interventions
test group:Tengshen Granules
Placebo group:Tengshen Granule Placebo
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years old. 2.Meet the Western medicine diagnostic criteria and TCM diagnostic criteria for grade 1 hypertension (severe liver heat and yang hyperactivity, mild kidney yin deficiency); 3.Determined as grade 1 primary hypertension and intermediate-risk patients based on blood pressure level and cardiovascular risk stratification for hypertension, with blood pressure meeting any one of the following three conditions: (1) Systolic blood pressure 140-159 mmHg and (or) diastolic blood pressure 90-99 mmHg, no antihypertensive drugs have been taken in the past 6 months, and no complications such as heart, brain and kidney are observed; (2) Those who have been clearly diagnosed with primary hypertension, and their blood pressure has not reached the target after improving their lifestyle or other forms of non-drug treatment for more than 3 months, and is maintained at systolic blood pressure 140-159 and (or) diastolic blood pressure 90-99 mmHg; (3) Those who have been clearly diagnosed with hypertension for a course of more than 3 months. 4.Those who have given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with secondary hypertension. 2.Those who have received other new drug clinical trials in the past 3 months. 3.Pregnant or pregnant women and breastfeeding women. 4.Those who have been allergic to multiple drugs or have allergic constitutions. 5.Those with mental illness, alcoholism and/or psychoactive substance abuse and dependence. 6.Those who drink excessive amounts of tea, coffee or caffeinated beverages every day. 7.Type 1 diabetes or type 2 diabetes with poor blood sugar control (fasting blood sugar>11mmol/L) or complications (nephropathy, peripheral neuropathy). 8.Gastrointestinal lesions or gastrointestinal surgery that may affect drug absorption and other serious digestive system diseases. 9.Those with the following organ damage or diseases: 12-month history of cerebrovascular disease (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral infarction and transient ischemic attack); 3-month history of acute coronary syndrome; decompensated heart failure (NYHA Grade III to IV); renal insufficiency (creatinine greater than the upper limit of normal); abnormal liver function (ALT, AST greater than 1.5 times the upper limit of normal); active, recurrent digestive ulcers or other bleeding risk diseases; combined with malignant tumors, blood system diseases or other systemic serious or progressive diseases. 10.Patients who have used antihypertensive drugs or are currently taking antihypertensive drugs in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM Syndrome Score;Blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score; | — |
Countries
China
Contacts
Public ContactLi Yunlun
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed