Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Official Title
-----------------
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Hypertension,Essential

Intervention / Treatment
-----------------
* Drug: Songling Xuemaikang Capsules
* Behavioral: Lifestyle intervention
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 35-65 years old, male or female; Grade 1 essential hypertension; Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ; Sign the informed consent; Exclusion Criteria: Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR<60ml/(min·1. 73m2); Gastrointestinal diseases, which may affect drug absorption; Be allergic to the clinical trial medicine; Pregnant or breastfeeding women, men who plan to give birth within half a year; Combined with other serious primary diseases or malignant tumors; Hyperlipidemia with or without taking lipid-lowering drugs; Combined with left ventricular hypertrophy, ABI < 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque; Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes); Other serious conditions in which is not fit for the study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention + Songling Xuemaikang Capsules<br>Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks | Drug: Songling Xuemaikang Capsules<br>* 3 capsules at a time, three times a day, duration: 12 weeks<br>Behavioral: Lifestyle intervention<br>* everyday, duration: 12 weeks<br>|
| Placebo Comparator: Lifestyle intervention + placebo<br>Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks placebo, 3 capsules at a time, three times a day, duration: 12 weeks | Behavioral: Lifestyle intervention<br>* everyday, duration: 12 weeks<br>Drug: Placebo<br>* 3 capsules at a time, three times a day, duration: 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and Week 4,12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the ba-PWV at 4,12 weeks | Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value) | 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) | 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) | 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) | 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) | 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) | Baseline and Week 4,12 | 
| Change 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | Week 12 | 
| Change from Baseline in the CIMT at 4,12 weeks | Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value) | 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) | 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) | 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) | Baseline and Week 4,12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension