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

Официальное название

Effect of the Traditional Chinese Medicine Yufeng Ningxin in Patients With Hypertension: a Randomized, Double-blind, Placebo-controlled Trial

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change from baseline in office SBP at Week 8 [Срок оценки: 8 weeks from treatment initiation.]

Вторичные конечные точки (12)

• Change from baseline in office DBP at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in mean daytime ambulatory SBP/DBP at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8. [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in Headache Disability Index (HDI) score at Week 8. [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in species-level relative abundance of gut microbiota assessed by metagenomic shotgun sequencing at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in alpha-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in beta-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8. [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in functional profile of gut microbiota assessed by metagenomic shotgun sequencing at Week 8. [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in plasma and fecal metabolomic profiles at Week 8 [Срок оценки: 8 weeks from treatment initiation.]
• Change from baseline in total cholesterol concentration at Week 8. [Срок оценки: 8 weeks from treatment initiation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 16 центров

• Beijing Anzhen Hospital — Пекин
• Chinese PLA General Hospital — Пекин
• Fuwai Hospital, Chinese Academy of Medical Sciences — Пекин
• Peking University First Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Second Affiliated Hospital of Dalian Medical University — Dalian
• Inner Mongolia People's Hospital — Hohhot
• Longyan First Hospital — Longyan
• … и ещё 8 центров

Идентификаторы

NCT: NCT07607275 · KS2025249

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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