Recruiting NCT06093932
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Songling Xuemaikang Capsules, Lifestyle intervention, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension,Essential. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
Overview
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
- Drug Songling Xuemaikang Capsules
3 capsules at a time, three times a day, duration: 12 weeks - Behavioral Lifestyle intervention
everyday, duration: 12 weeks - Drug Placebo
3 capsules at a time, three times a day, duration: 12 weeks
Primary outcome measures
- Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
Secondary outcome measures (12)
- Change from Baseline in the ba-PWV at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the skin capillary density(SCD) at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Mean 24h PP at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the BP load at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Official PP at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Official SBP at 4,12 weeks [Time frame: Baseline and Week 4,12]
- Change from Baseline in the Official DBP at 4,12 weeks [Time frame: Baseline and Week 4,12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Xiyuan Hospital of China Academy of Chinese Medical Sciences — Beijing
- Suzhou Hosptial of Traditional Chinese Medicine — Suzhou
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan
- China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital — Jining
- China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital — Taiyuan
Publications
- 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. PMID 33019798
- Liu Q, Yu L, Zhang Z, Zhuang Z, Tian W, Wang A, Xu H. The effects of Songling Xuemaikang capsule on vascular remodeling of stage 1 hypertension: a multicenter, randomized placebo-controlled trial protocol. BMC Complement Med Ther. 2025 Aug 6;25(1):300. doi: 10.1186/s12906-025-05038-y. PMID 40770317
Identifiers
NCT: NCT06093932 · 2023XL012-3