A multicenter, randomized, double-blind, placebo-controlled clinical study of Fuyuan granule in the intervention of borderline hypertensio
- Conditions
- borderline hypertension
- Registration Number
- ITMCTR2022000040
- Lead Sponsor
- Eye Hospital, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Age 18 ~ 65 years old; (2) Systolic blood pressure 120 ~ 139mmHg and / or diastolic blood pressure 80 ~ 89mmHg; (3) The blood pressure was not controlled by western medicine, traditional Chinese medicine or acupuncture (or the treatment method was stopped for 2 weeks); (4) Willing to be randomly assigned to active and passive intervention technology group and control group; (5) Able to perform mild to moderate exercise; (6) Volunteer to participate in the trial and sign the informed consent form.
(1) Secondary hypertension; (2) Pregnant and lactating women; (3) Non dominant arm circumference > 50cm; (4) Body mass index = 40.0kg/m2; (5) Taking benzodiazepines, antipsychotics or oral glucocorticoids (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram are allowed to be used stably within 3 months); (6) Diagnose coronary heart disease; (7)ALT and AST > 2 times the upper limit of normal value; Chronic kidney disease with Cr > 2 times the upper limit of normal value and EGFR < 60ml/min (refer to the normal value range of laboratory examination in the research center) (8) Known autonomic neuropathy; (such as shy Drager syndrome, orthostatic hypotension, white coat hypertension); (9) Male alcohol intake = 25g/ day (about 65ml Beijing Erguotou), or = 140g/ week; Female = 15g/ day (about 33ml Beijing Erguotou), or = 80g/ week; (10) Complicated with malignant tumor, blood, digestive or other serious or progressive diseases; (11) The investigator believes that it is not appropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Office blood pressure;
- Secondary Outcome Measures
Name Time Method Changes in cardiovascular risk assessment;Changes in Body mass scale;Changes in mean 24-hour ambulatory blood pressure and blood pressure variability;Changes in four blood lipids;