Recruiting PHASE4 Hypertension

New treatment option for Hypertension

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

ClinicalTrials.gov ID: NCT07607275

What this study is testing

What is Yufeng Ningxin tablets?

Yufeng Ningxin tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypertension.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join 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...
  • The patient is capable of understanding the study requirements, is willing and able to comply with study procedures, and has provided written...

You likely can't join if

  • Secondary hypertension (including, but not limited to, renovascular hypertension, pheochromocytoma, primary aldosteronism, Cushing syndrome, aortic...
  • 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...
  • Users of prescription non-steroidal anti-inflammatory drugs (NSAIDs); initiation of, changes to, or discontinuation of sodium-glucose co-transporter...
  • 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);
See the full eligibility criteria
Who can 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...
  • The patient is capable of understanding the study requirements, is willing and able to comply with study procedures, and has provided written informed consent.
What rules you out
  • 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...
  • 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...
  • 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...
  • 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;
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, China
  • Chongqing, China
  • Dalian, China
  • Hohhot, China
  • Longyan, China
  • Luohe, China
  • Nanchang, China
  • Nanjing, China
  • Shantou, China
  • Taiyuan, China
  • Tianjin, China
  • Wuhan, China
  • Xiamen, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, China; Chongqing, China; Dalian, China; Hohhot, China; Longyan, China; Luohe, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.