Effect of Songling Xuemaikang Capsules on mild hypertension
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
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 |
| Enrollment | 100 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Trial ID | NCT06093932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-65 with grade 1 essential hypertension who are not regularly taking antihypertensive medications.
Not a fit: Patients with significant liver or kidney dysfunction, serious comorbidities, or those currently on antihypertensive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing grade 1 hypertension.
How similar studies have performed: While the specific approach of using Songling Xuemaikang Capsules is novel, similar studies on herbal interventions for hypertension have shown promising results.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.