Effect of the Traditional Chinese Medicine Yufeng Ningxin in Patients With Hypertension

NCT07607275 | Recruiting Phase 4

• 1 other identifier: KS2025249
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 16

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.

Conditions

Hypertension; Essential (Primary) Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in office SBP at Week 8

  8 weeks from treatment initiation.

Secondary Outcomes (17)

• 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.

Study Arms (2)

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.

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.

Drug: Yufeng Ningxin tablets

Interventions

Yufeng Ningxin tablets DRUG

Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.

Treatment group

Placebo DRUG

Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (16)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

Chinese PLA General Hospital

Beijing, China

RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

RECRUITING

Inner Mongolia People's Hospital

Hohhot, China

NOT YET RECRUITING

Longyan First Hospital

Longyan, China

NOT YET RECRUITING

Luohe Central Hospital

Luohe, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

NOT YET RECRUITING

The Second Affiliated Hospital of Shantou University Medical College

Shantou, China

NOT YET RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, China

NOT YET RECRUITING

Tianjin Kanghui Hospital

Tianjin, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ruixue Yang, MD

CONTACT

+86-10-81992130; yangruixue2020@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Hypertension Center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 26, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)