Clinical trial NCT06093932: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
Official title: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertension,Essential
Keywords: Songling Xuemaikang Capsules
Vascular remodeling
Grade 1 hypertension
Mild hypertension
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
name: Suzhou Hosptial of Traditional Chinese Medicine
name: China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
name: Shandong University of Traditional Chinese Medicine
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
Secondary outcomes:
measure: Change from Baseline in the ba-PWV at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Mean 24h PP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the BP load at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Official PP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Official SBP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Official DBP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Home SBP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Home DBP at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
timeFrame: Week 12
measure: Change from Baseline in the CIMT at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
timeFrame: Baseline and Week 4,12
measure: Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
timeFrame: Baseline and Week 4,12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Suzhou
country: China
facility: Suzhou Hosptial of Traditional Chinese Medicine
state: Jiangsu
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Jining
country: China
facility: China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
state: Shandong
city: Taiyuan
country: China
facility: China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
state: Shanxi
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Hao Xu, Prof.
role: STUDY_CHAIR
References:
citation: Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6.