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Clinical Trials in China / NCT06093932
Recruiting Phase 4

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

NCT06093932 · tracked via the Priya Life Science China tracker
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase
Phase 4
Started
2024-04-07
Last updated
2024-08-20

Condition(s) studied

Hypertension,Essential

Investigational drug(s) / intervention(s)

Songling Xuemaikang Capsules →Lifestyle interventionPlacebo

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

Lifestyle intervention: everyday, duration: 12 weeks

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

Study 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

Sex
ALL
Min age
35 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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)

Trial sites (5)

FacilityCityRegionStatus
Xiyuan Hospital of China Academy of Chinese Medical Sciences Beijing Beijing Municipality Recruiting
Suzhou Hosptial of Traditional Chinese Medicine Suzhou Jiangsu Not Yet Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong Not Yet Recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital Jining Shandong Not Yet Recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital Taiyuan Shanxi Not Yet Recruiting

More Xiyuan Hospital of China Academy of Chinese Medical Sciences trials in China

Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome Starting soon
Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol Starting soon
Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome Recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome Starting soon

Other trials for the same condition

Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06093932 on ClinicalTrials.gov ↗ ← All trials in China