Effect of Songling Xuemaikang Capsules on mild hypertension
Official title: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
Run by Xiyuan Hospital of China Academy of Chinese Medical Sciences · NCT06093932 · Data updated 2026-11-12
This study tests whether Songling Xuemaikang Capsules can help people with mild high blood pressure improve their heart and blood vessel health compared to a lifestyle change or a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | April 7, 2024 |
| Main results expected | December 2024 |
| Study ends | December 2027 |
| Registry record updated | August 20, 2024 |
| Trial ID | NCT06093932 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 35-65 with grade 1 essential hypertension who are not regularly taking antihypertensive medications.
✕Probably not a fit
Patients with significant liver or kidney dysfunction, serious comorbidities, or those currently on antihypertensive medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy of Songling Xuemaikang Capsules (SLXMKC) in patients with grade 1 essential hypertension. It aims to assess the capsules' impact on vascular function and structure, as well as to explore the underlying mechanisms of their therapeutic effects. Participants will receive either the SLXMKC, a lifestyle intervention, or a placebo in a randomized controlled format. The study targets individuals aged 35-65 who have not been consistently taking antihypertensive medications.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing grade 1 hypertension.
How similar studies have gone: While the specific approach of using Songling Xuemaikang Capsules is novel, similar studies on herbal interventions for hypertension have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China Recruiting -
Suzhou Hosptial of Traditional Chinese Medicine
Suzhou, Jiangsu, China Not yet recruiting -
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China Not yet recruiting -
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Jining, Shandong, China Not yet recruiting -
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Taiyuan, Shanxi, China Not yet recruiting
Study contacts
- Study coordinator: Anlu Wang, Doctor
- Email: wwanganlu@126.com
- Phone: 010-62835342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.