Hypertension(Grade I)
Conditions
Interventions
Positive control group:Losartan potassium tablet + Niuhuang Jiangya pill analog agent: Niuhuang Jiangya pill2 pill / time 1 pill / day
losartan potassium tablet 1 tablet / day.
Experimental group:Niuhuang Jiangya pill + losartan potassium tablet analog agent: Niuhuang Jiangya pill 2 pills / time 1 time / day
losartan potassium tablet analog agent 1 tablet / day.
Sponsors
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria of essential hypertension hypertension grade 1 and diastolic blood pressure=90mmHg; 2.Meet the diagnostic criteria of effulgent heart-liver fire syndrome type; 3.No treatment for hypertension or withdrawal of antihypertensive drugs for at least 2 weeks; 4.18 to 75 years old including boundary value gender limitation; 5.Volunteer to participate in this study and written informed consent was obtained from each patient or their guardians.
Exclusion criteria
Exclusion criteria: 1.Patients with unstable cardiovascular and cerebrovascular diseases within half a year including but not limited to: cerebral hemorrhage ischemic stroke transient cerebral ischemia myocardial infarction unstable angina pectoris coronary revascularization acute heart failure atrial fibrillation structural heart disease (such as heart valve disease) etc.; 2.Patients with kidney disease: increased creatinine (133 µ mol/L in men; 124 µ mol/L in females); 3.Patients with type 2 diabetes with type 1 diabetes or poor glycemic control (fasting glucose 10.0mmol/L or glyc hemoglobin 8.5%); 4.Patients with bilateral renal artery stenosis and isolated kidney; 5.Patients with a medical history of malignant tumors; 6.Patients with repeated chronic diarrhea in the past half a year or diarrhea in the past one month or other contraindications of Niuhuang Jiangya pill; 7.Patients with bezoar antihypertensive pill or losartan potassium; 8.Known or suspected allergy to the test drug losartan potassium and its excipients; 9.Participation in clinical trials of other drugs or devices within 1 month prior to enrollment; 10.Those with severe mental illness as judged by the investigator as unable to complete the trial; 11.Female subjects who are pregnant breastfeeding or planned to become pregnant during the trial; 12.Clinically significant laboratory abnormalities including but not limited to: blood potassium> 5.5 mmol L / L; blood ALT and / or AST> 2.5 upper limit of normal (ULN); any clinically significant laboratory abnormalities that the investigator considers may interfere with the evaluation of the efficacy and / or safety data of the study; 13.Take drugs for hypertension including the same type of proprietary Chinese patent medicine or decoction; 14.Patients unsuitable by the investigator to participate in the study due to possible violations of the trial protocol or any other conditions that affect their safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diastolic pressure of the upper arm artery in the clinic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypertension hormone;Depressive symptoms score;Blood pressure response rate (number of hypertension standard / total number of hypertension * 100%);Anxiety symptom score;Traditional Chinese medicine symptom score;Systolic pressure of the upper arm artery in the clinic;Pittsburgh sleep quality index;Objective evaluation of sleep quality (actigraph);Hypertension symptom score;24 hours Ambulatory blood pressure; | — |
Countries
China
Contacts
Public ContactXU Fengqin
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Outcome results
None listed