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

29 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

350

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Beijing, Cina
        • Reclutamento
        • Chinese PLA General Hospital
        • Contatto:
          • Zongbin Li, MD
        • Investigatore principale:
          • Zongbin Li
      • Beijing, Cina
        • Reclutamento
        • Beijing Anzhen Hospital
        • Investigatore principale:
          • Jun Cai
        • Contatto:
      • Beijing, Cina
        • Non ancora reclutamento
        • Peking University First Hospital
        • Investigatore principale:
          • Yan Zhang
        • Contatto:
          • Yan Zhang
      • Beijing, Cina
        • Non ancora reclutamento
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contatto:
          • Wenjun Ma
        • Investigatore principale:
          • Wenjun Ma
      • Chongqing, Cina
        • Non ancora reclutamento
        • The First Affiliated Hospital of Chongqing Medical University
        • Contatto:
          • Jing Chang
        • Investigatore principale:
          • Jing Chang
      • Dalian, Cina
        • Reclutamento
        • The Second Affiliated Hospital of Dalian Medical University
        • Contatto:
          • Yanchun Ding
        • Investigatore principale:
          • Yanchun Ding
      • Hohhot, Cina
        • Non ancora reclutamento
        • Inner Mongolia People's Hospital
        • Contatto:
          • Xinjun Guo
        • Investigatore principale:
          • Xinjun Guo
      • Longyan, Cina
        • Non ancora reclutamento
        • Longyan First Hospital
        • Contatto:
          • Wuyang Zheng
        • Investigatore principale:
          • Wuyang Zheng
      • Luohe, Cina
        • Reclutamento
        • Luohe Central Hospital
        • Contatto:
          • Qiaotao Xie
        • Investigatore principale:
          • Qiaotao Xie
      • Nanchang, Cina
        • Reclutamento
        • The Second Affiliated Hospital of Nanchang University
        • Contatto:
          • Yifei Dong
        • Investigatore principale:
          • Yifei Dong
      • Nanjing, Cina
        • Non ancora reclutamento
        • Jiangsu Province Hospital
        • Contatto:
          • Wei Sun
        • Investigatore principale:
          • Wei Sun
      • Shantou, Cina
        • Non ancora reclutamento
        • The Second Affiliated Hospital Of Shantou University Medical College
        • Contatto:
          • Youren Chen
        • Investigatore principale:
          • Youren Chen
      • Taiyuan, Cina
        • Non ancora reclutamento
        • First Hospital of Shanxi Medical University
        • Contatto:
          • Juyan Zhang
        • Investigatore principale:
          • Juyan zhang
      • Tianjin, Cina
        • Reclutamento
        • Tianjin Kanghui Hospital
        • Investigatore principale:
          • Ning Yang
        • Contatto:
          • Ning Yang
      • Wuhan, Cina
        • Non ancora reclutamento
        • Renmin Hospital of Wuhan University
        • Contatto:
          • Hongxin Xu
        • Investigatore principale:
          • Hongxin Xu
      • Xiamen, Cina
        • Reclutamento
        • The First Affiliated Hospital of Xiamen University
        • Contatto:
          • Zhengrong Huang
        • Investigatore principale:
          • Zhengrong Huang

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change from baseline in office SBP at Week 8
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in office DBP at Week 8
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean daytime ambulatory SBP/DBP at Week 8
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in total cholesterol concentration at Week 8.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Anzhen Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KS2025249

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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