Essential (Primary) Hypertension, Hypertension
Conditions
Brief summary
Yufeng Ningxin, a traditional Chinese medicine, has demonstrated potential antihypertensive effects in animal studies and small clinical trials, but has not yet been rigorously evaluated in large randomized clinical trials. Here, the investigators conducted a double-blind, randomized controlled trial to assess the efficacy and safety of Yufeng Ningxin tablets in patients with hypertension.
Interventions
DRUGYufeng Ningxin tablets
Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.
DRUGPlacebo
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female participants aged 18-65 years; 2. Newly diagnosed, untreated hypertension or treated hypertension with a seated systolic blood pressure of 140-159 mmHg and a daytime mean ambulatory systolic blood pressure ≥135 mmHg, following a ≥2-week washout of background antihypertensive medications; 3. The patient is capable of understanding the study requirements, is willing and able to comply with study procedures, and has provided written informed consent.
Exclusion criteria
1. Secondary hypertension (including, but not limited to, renovascular hypertension, pheochromocytoma, primary aldosteronism, Cushing syndrome, aortic coarctation, or due to known history of moderate-to-severe obstructive sleep apnea); 2. Orthostatic hypotension (symptomatic or asymptomatic); 3. Participation in another hypertension-related clinical trial at enrollment or within 6 months prior; 4. Currently taking, taken within 30 days prior to randomization, or anticipated to receive during the study treatment period any medication or herbal supplement known to significantly affect blood pressure (with the exception of medications for the treatment of essential hypertension). These drugs include, but are not limited to: organic nitrates, glucocorticoids (excluding topical or inhaled corticosteroids), central nervous system stimulants (e.g., methylphenidate, dexmethylphenidate, amphetamines), estrogens, monoamine oxidase inhibitors, digitalis preparations, Chinese proprietary medicines (such as Tianma Gouteng Granules, Songling Xuemaikang Capsules, Yangxue Qingnao Granules), and herbal medicines (including Salvia miltiorrhiza, Uncaria rhynchophylla, Ginkgo biloba leaves, Prunella vulgaris, etc.); 5. Users of prescription non-steroidal anti-inflammatory drugs (NSAIDs); initiation of, changes to, or discontinuation of sodium-glucose co-transporter (SGLT2) inhibitor therapy within 4 weeks prior to screening. Patients who were stably taking an SGLT2 inhibitor or low-dose aspirin (defined as ≤100mg per day) for at least 4 weeks prior to screening with no anticipated changes during the study are permitted; 6. Severe hepatic or renal diseases (ALT \>3 times the upper limit of normal value, or end stage renal disease on dialysis, or eGFR \<30 mL/min/1.73 m2); 7. Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c\>9.0%); 8. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack \[TIA\]); 9. Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 6 months; 10. Sustained atrial fibrillation or arrhythmias interfering with electronic BP measurement; 11. NYHA class III-IV heart failure, or hospitalization for chronic heart failure exacerbation within the past 6 months; 12. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period; 13. Dilated cardiomyopathy, hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease; 14. Other severe diseases that may affect participant enrollment or survival, such as malignancy or acquired immunodeficiency syndrome (AIDS); 15. Cognitive impairment or severe neuropsychiatric comorbidities that render the patient incapable of providing informed consent; 16. Participants preparing for or under pregnancy and/or lactation; 17. Frequent night-shift work, with primary working hours during nighttime (e.g., 8:00 PM to 8:00 AM); 18. Other conditions deemed inappropriate for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in office SBP at Week 8 | 8 weeks from treatment initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in office DBP at Week 8 | 8 weeks from treatment initiation. | — |
| Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8 | 8 weeks from treatment initiation. | — |
| Change from baseline in mean daytime ambulatory SBP/DBP at Week 8 | 8 weeks from treatment initiation. | — |
| Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8 | 8 weeks from treatment initiation. | — |
| Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8. | 8 weeks from treatment initiation. | The Headache Impact Test-6 (HIT-6), a 6-item questionnaire, will be used as part of the evaluation for headache symptoms to assess the impact of headaches on daily life. Each item is scored as 6 (never), 8 (rarely), 10 (sometimes), 11 (very often), or 13 (always) points. Total scores range from 36 to 78, with higher scores indicating a greater impact (worse outcome). The "change from baseline" is calculated as the score at Week 8 minus the score at baseline. |
| Change from baseline in Headache Disability Index (HDI) score at Week 8. | 8 weeks from treatment initiation. | The Headache Disability Index (HDI), a 25-item tool designed to assess the impact of headache on daily activities and emotional well-being, will be used as part of the evaluation for headache symptoms. Each item is scored as 4 (yes), 2 (sometimes), or 0 (no). The total score ranges from 0 to 100, where higher scores indicate greater headache-related disability (worse outcome). The "change from baseline" is calculated as the score at Week 8 minus the score at baseline. |
| Change from baseline in species-level relative abundance of gut microbiota assessed by metagenomic shotgun sequencing at Week 8 | 8 weeks from treatment initiation. | The species-level relative abundance (%) of the gut microbiota will be analyzed using metagenomic shotgun sequencing of fecal samples. |
| Change from baseline in alpha-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8 | 8 weeks from treatment initiation. | Alpha-diversity: Evaluated by the Shannon index to measure community richness and evenness. |
| Change from baseline in beta-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8. | 8 weeks from treatment initiation. | Beta-diversity: Evaluated by Bray-Curtis dissimilarity to assess structural differences between microbial communities. |
| Change from baseline in functional profile of gut microbiota assessed by metagenomic shotgun sequencing at Week 8. | 8 weeks from treatment initiation. | Functional profile: The characterization of gut microbial functions based on databases such as KEGG (Kyoto Encyclopedia of Genes and Genomes) and MetaCyc. |
| Change from baseline in plasma and fecal metabolomic profiles at Week 8 | 8 weeks from treatment initiation. | — |
| Change from baseline in total cholesterol concentration at Week 8. | 8 weeks from treatment initiation. | The serum concentration of total cholesterol (TC) will be measured in a certified clinical laboratory. |
| Change from baseline in triglycerides concentration at Week 8. | 8 weeks from treatment initiation. | The serum concentration of triglycerides (TG) will be measured in a certified clinical laboratory. |
| Change from baseline in low-density lipoprotein cholesterol concentration at Week 8. | 8 weeks from treatment initiation. | The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured in a certified clinical laboratory. |
| Change from baseline in high-density lipoprotein cholesterol concentration at Week 8. | 8 weeks from treatment initiation. | The concentration of high-density lipoprotein cholesterol (HDL-C) will be measured in a certified clinical laboratory. |
| Change from baseline in the fasting blood glucose concentration at Week 8. | 8 weeks from treatment initiation. | This outcome measure assesses the change in the fasting blood glucose concentration. All assessments are performed in a certified clinical laboratory. |
| Incidence of a composite safety outcome (including all-cause mortality, hospitalizations, emergency visits, and adverse events) during the 8-week period. | 8 weeks from treatment initiation. | This composite outcome measure tracks the overall safety profile of the intervention. It is defined as the number of participants experiencing at least one of the following safety-related events: (1) all-cause mortality; (2) hospitalizations or emergency visits; (3) adverse events. |
Countries
China
Contacts
CONTACTRuixue Yang, MD
Outcome results
None listed