HypertensionPhase 4NCT07607275
Effect of the Traditional Chinese Medicine Yufeng Ningxin in Patients With Hypertension
A Phase 4 study testing Yufeng Ningxin tablets in people with Hypertension and Essential (Primary) Hypertension, run by Beijing Anzhen Hospital at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Essential (Primary) Hypertension
- What is being tested?
- Yufeng Ningxin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 16 sitesChina
- Study dates
- 15 May 2026to 1 Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18-65 years;
- 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;
- The patient is capable of understanding the study requirements, is willing and able to comply with study procedures, and has provided written informed consent.
Who cannot join
- 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);
- Orthostatic hypotension (symptomatic or asymptomatic);
- Participation in another hypertension-related clinical trial at enrollment or within 6 months prior;
- 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.);
- 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;
- 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);
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- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c>9.0%);
- History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack [TIA]);
- 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;
- Sustained atrial fibrillation or arrhythmias interfering with electronic BP measurement;
- NYHA class III-IV heart failure, or hospitalization for chronic heart failure exacerbation within the past 6 months;
- Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period;
- Dilated cardiomyopathy, hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
- Other severe diseases that may affect participant enrollment or survival, such as malignancy or acquired immunodeficiency syndrome (AIDS);
- Cognitive impairment or severe neuropsychiatric comorbidities that render the patient incapable of providing informed consent;
- Participants preparing for or under pregnancy and/or lactation;
- Frequent night-shift work, with primary working hours during nighttime (e.g., 8:00 PM to 8:00 AM);
- Other conditions deemed inappropriate for participation by the investigators.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Jun Cai, +86-10-81992130, caijun7879@126.com
Jun Cai
- Recruiting
Chinese PLA General Hospital
Beijing
Zongbin Li, MD
Zongbin Li
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
Wenjun Ma
Wenjun Ma
- Recruiting
Peking University First Hospital
Beijing
Yan Zhang
Yan Zhang
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Jing Chang
Jing Chang
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian
Yanchun Ding
Yanchun Ding
- Not yet recruiting
Inner Mongolia People's Hospital
Hohhot
Xinjun Guo
Xinjun Guo
- Not yet recruiting
Longyan First Hospital
Longyan
Wuyang Zheng
Wuyang Zheng
- Recruiting
Luohe Central Hospital
Luohe
Qiaotao Xie
Qiaotao Xie
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Yifei Dong
Yifei Dong
- Recruiting
Jiangsu Province Hospital
Nanjing
Wei Sun
Wei Sun
- Recruiting
The Second Affiliated Hospital of Shantou University Medical College
Shantou
Youren Chen
Youren Chen
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan
Juyan Zhang
Juyan zhang
- Recruiting
Tianjin Kanghui Hospital
Tianjin
Ning Yang
Ning Yang
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan
Hongxin Xu
Hongxin Xu
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Zhengrong Huang
Zhengrong Huang
About this study
Official title: Effect of the Traditional Chinese Medicine Yufeng Ningxin in Patients With Hypertension: a Randomized, Double-blind, Placebo-controlled Trial
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.
- Conditions
- Hypertension, Essential (Primary) Hypertension
- Being tested
- Yufeng Ningxin tablets, Placebo
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yufeng Ningxin tabletsDrug
Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.
PlaceboDrug
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks. Receives: Drug: Placebo |
| Treatment group | Experimental | Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks. Receives: Drug: Yufeng Ningxin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in office SBP at Week 8
Measured: 8 weeks from treatment initiation.
Secondary outcomes (17)
Change from baseline in office DBP at Week 8
Measured: 8 weeks from treatment initiation.
Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8
Measured: 8 weeks from treatment initiation.
Change from baseline in mean daytime ambulatory SBP/DBP at Week 8
Measured: 8 weeks from treatment initiation.
Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8
Measured: 8 weeks from treatment initiation.
Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8.
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.
Measured: 8 weeks from treatment initiation.
Change from baseline in Headache Disability Index (HDI) score at Week 8.
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.
Measured: 8 weeks from treatment initiation.
Change from baseline in species-level relative abundance of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
The species-level relative abundance (%) of the gut microbiota will be analyzed using metagenomic shotgun sequencing of fecal samples.
Measured: 8 weeks from treatment initiation.
Change from baseline in alpha-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
Alpha-diversity: Evaluated by the Shannon index to measure community richness and evenness.
Measured: 8 weeks from treatment initiation.
Change from baseline in beta-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Beta-diversity: Evaluated by Bray-Curtis dissimilarity to assess structural differences between microbial communities.
Measured: 8 weeks from treatment initiation.
Change from baseline in functional profile of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Functional profile: The characterization of gut microbial functions based on databases such as KEGG (Kyoto Encyclopedia of Genes and Genomes) and MetaCyc.
Measured: 8 weeks from treatment initiation.
Change from baseline in plasma and fecal metabolomic profiles at Week 8
Measured: 8 weeks from treatment initiation.
Change from baseline in total cholesterol concentration at Week 8.
The serum concentration of total cholesterol (TC) will be measured in a certified clinical laboratory.
Measured: 8 weeks from treatment initiation.
Change from baseline in triglycerides concentration at Week 8.
The serum concentration of triglycerides (TG) will be measured in a certified clinical laboratory.
Measured: 8 weeks from treatment initiation.
Change from baseline in low-density lipoprotein cholesterol concentration at Week 8.
The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured in a certified clinical laboratory.
Measured: 8 weeks from treatment initiation.
Change from baseline in high-density lipoprotein cholesterol concentration at Week 8.
The concentration of high-density lipoprotein cholesterol (HDL-C) will be measured in a certified clinical laboratory.
Measured: 8 weeks from treatment initiation.
Change from baseline in the fasting blood glucose concentration at Week 8.
This outcome measure assesses the change in the fasting blood glucose concentration. All assessments are performed in a certified clinical laboratory.
Measured: 8 weeks from treatment initiation.
Incidence of a composite safety outcome (including all-cause mortality, hospitalizations, emergency visits, and adverse events) during the 8-week period.
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.
Measured: 8 weeks from treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Cai, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607275
- Sponsor's protocol ID
- KS2025249
- Status last verified
- Sep 2026
- First submitted
- 7 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No