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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06093932

Acronym

ESCIHP

Enrollment

100

Registered

2023-10-23

Start date

2024-04-07

Completion date

2027-12-31

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension

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.

Interventions

DRUGSongling Xuemaikang Capsules

3 capsules at a time, three times a day, duration: 12 weeks

BEHAVIORALLifestyle intervention

everyday, duration: 12 weeks

DRUGPlacebo

3 capsules at a time, three times a day, duration: 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Secondary

Measure	Time frame	Description
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Mean 24h PP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the BP load at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Official PP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the ba-PWV at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Official DBP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Home SBP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Home DBP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks	Week 12	Proportion= Number of target patients/Total patients
Change from Baseline in the CIMT at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Change from Baseline in the Official SBP at 4,12 weeks	Baseline and Week 4,12	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

Countries

China

Contacts

Primary ContactAnlu Wang, Doctor

wwanganlu@126.com010-62835342

Backup ContactQiyu Liu, Doctor

liuqy9307@163.com010-18810722937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026