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

Phase 4

Recruiting

• Conditions: Hypertension,Essential
• Interventions: Drug: Songling Xuemaikang Capsules; Behavioral: Lifestyle intervention; Drug: Placebo

• Registration Number: NCT06093932
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Study Start: 2024-04-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-17
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention + Songling Xuemaikang Capsules	Songling Xuemaikang Capsules	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention + Songling Xuemaikang Capsules	Lifestyle intervention	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention + placebo	Lifestyle intervention	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention + placebo	Placebo	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 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 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 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 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)

Trial Locations

Locations (5)

China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital; 🇨🇳 Taiyuan, Shanxi, China

Xiyuan Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Suzhou Hosptial of Traditional Chinese Medicine; 🇨🇳 Suzhou, Jiangsu, China

Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China

China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital; 🇨🇳 Jining, Shandong, China