The purpose of this study is: 1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension. 2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension. 3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
3 capsules at a time, three times a day, duration: 12 weeks
everyday, duration: 12 weeks
3 capsules at a time, three times a day, duration: 12 weeks
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGSuzhou Hosptial of Traditional Chinese Medicine
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGAffiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the ba-PWV at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
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China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Jining, Shandong, China
NOT_YET_RECRUITINGChina Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGChange from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean 24h PP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the BP load at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Official PP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Official SBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Official DBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Home SBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Home DBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
Proportion= Number of target patients/Total patients
Time frame: Week 12
Change from Baseline in the CIMT at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time frame: Baseline and Week 4,12