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

29 de mayo de 2026 actualizado por: Jun Cai, Beijing Anzhen Hospital

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

350

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Reclutamiento
        • Chinese PLA General Hospital
        • Contacto:
          • Zongbin Li, MD
        • Investigador principal:
          • Zongbin Li
      • Beijing, Porcelana
        • Reclutamiento
        • Beijing Anzhen Hospital
        • Investigador principal:
          • Jun Cai
        • Contacto:
      • Beijing, Porcelana
        • Aún no reclutando
        • Peking University First Hospital
        • Investigador principal:
          • Yan Zhang
        • Contacto:
          • Yan Zhang
      • Beijing, Porcelana
        • Aún no reclutando
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contacto:
          • Wenjun Ma
        • Investigador principal:
          • Wenjun Ma
      • Chongqing, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Chongqing Medical University
        • Contacto:
          • Jing Chang
        • Investigador principal:
          • Jing Chang
      • Dalian, Porcelana
        • Reclutamiento
        • The Second Affiliated Hospital of Dalian Medical University
        • Contacto:
          • Yanchun Ding
        • Investigador principal:
          • Yanchun Ding
      • Hohhot, Porcelana
        • Aún no reclutando
        • Inner Mongolia People's Hospital
        • Contacto:
          • Xinjun Guo
        • Investigador principal:
          • Xinjun Guo
      • Longyan, Porcelana
        • Aún no reclutando
        • Longyan First Hospital
        • Contacto:
          • Wuyang Zheng
        • Investigador principal:
          • Wuyang Zheng
      • Luohe, Porcelana
        • Reclutamiento
        • Luohe Central Hospital
        • Contacto:
          • Qiaotao Xie
        • Investigador principal:
          • Qiaotao Xie
      • Nanchang, Porcelana
        • Reclutamiento
        • The Second Affiliated Hospital of Nanchang University
        • Contacto:
          • Yifei Dong
        • Investigador principal:
          • Yifei Dong
      • Nanjing, Porcelana
        • Aún no reclutando
        • Jiangsu Province Hospital
        • Contacto:
          • Wei Sun
        • Investigador principal:
          • Wei Sun
      • Shantou, Porcelana
        • Aún no reclutando
        • The Second Affiliated Hospital of Shantou university Medical College
        • Contacto:
          • Youren Chen
        • Investigador principal:
          • Youren Chen
      • Taiyuan, Porcelana
        • Aún no reclutando
        • First Hospital of Shanxi Medical University
        • Contacto:
          • Juyan Zhang
        • Investigador principal:
          • Juyan zhang
      • Tianjin, Porcelana
        • Reclutamiento
        • Tianjin Kanghui Hospital
        • Investigador principal:
          • Ning Yang
        • Contacto:
          • Ning Yang
      • Wuhan, Porcelana
        • Aún no reclutando
        • Renmin Hospital of Wuhan University
        • Contacto:
          • Hongxin Xu
        • Investigador principal:
          • Hongxin Xu
      • Xiamen, Porcelana
        • Reclutamiento
        • The First Affiliated Hospital of Xiamen University
        • Contacto:
          • Zhengrong Huang
        • Investigador principal:
          • Zhengrong Huang

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Control group
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Droga: Placebo
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Experimental: Treatment group
Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from baseline in office SBP at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in office DBP at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean daytime ambulatory SBP/DBP at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8.
Periodo de tiempo: 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.
8 weeks from treatment initiation.
Change from baseline in Headache Disability Index (HDI) score at Week 8.
Periodo de tiempo: 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.
8 weeks from treatment initiation.
Change from baseline in species-level relative abundance of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
The species-level relative abundance (%) of the gut microbiota will be analyzed using metagenomic shotgun sequencing of fecal samples.
8 weeks from treatment initiation.
Change from baseline in alpha-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
Alpha-diversity: Evaluated by the Shannon index to measure community richness and evenness.
8 weeks from treatment initiation.
Change from baseline in beta-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Periodo de tiempo: 8 weeks from treatment initiation.
Beta-diversity: Evaluated by Bray-Curtis dissimilarity to assess structural differences between microbial communities.
8 weeks from treatment initiation.
Change from baseline in functional profile of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Periodo de tiempo: 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.
8 weeks from treatment initiation.
Change from baseline in plasma and fecal metabolomic profiles at Week 8
Periodo de tiempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in total cholesterol concentration at Week 8.
Periodo de tiempo: 8 weeks from treatment initiation.
The serum concentration of total cholesterol (TC) will be measured in a certified clinical laboratory.
8 weeks from treatment initiation.
Change from baseline in triglycerides concentration at Week 8.
Periodo de tiempo: 8 weeks from treatment initiation.
The serum concentration of triglycerides (TG) will be measured in a certified clinical laboratory.
8 weeks from treatment initiation.
Change from baseline in low-density lipoprotein cholesterol concentration at Week 8.
Periodo de tiempo: 8 weeks from treatment initiation.
The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured in a certified clinical laboratory.
8 weeks from treatment initiation.
Change from baseline in high-density lipoprotein cholesterol concentration at Week 8.
Periodo de tiempo: 8 weeks from treatment initiation.
The concentration of high-density lipoprotein cholesterol (HDL-C) will be measured in a certified clinical laboratory.
8 weeks from treatment initiation.
Change from baseline in the fasting blood glucose concentration at Week 8.
Periodo de tiempo: 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.
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.
Periodo de tiempo: 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.
8 weeks from treatment initiation.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Beijing Anzhen Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KS2025249

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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