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

29. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

350

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Chinese PLA General Hospital
        • Ta kontakt med:
          • Zongbin Li, MD
        • Hovedetterforsker:
          • Zongbin Li
      • Beijing, Kina
        • Rekruttering
        • Beijing Anzhen Hospital
        • Hovedetterforsker:
          • Jun Cai
        • Ta kontakt med:
      • Beijing, Kina
        • Har ikke rekruttert ennå
        • Peking University First Hospital
        • Hovedetterforsker:
          • Yan Zhang
        • Ta kontakt med:
          • Yan Zhang
      • Beijing, Kina
        • Har ikke rekruttert ennå
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Ta kontakt med:
          • Wenjun Ma
        • Hovedetterforsker:
          • Wenjun Ma
      • Chongqing, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Chongqing Medical University
        • Ta kontakt med:
          • Jing Chang
        • Hovedetterforsker:
          • Jing Chang
      • Dalian, Kina
        • Rekruttering
        • The Second Affiliated Hospital of Dalian Medical University
        • Ta kontakt med:
          • Yanchun Ding
        • Hovedetterforsker:
          • Yanchun Ding
      • Hohhot, Kina
        • Har ikke rekruttert ennå
        • Inner Mongolia People's Hospital
        • Ta kontakt med:
          • Xinjun Guo
        • Hovedetterforsker:
          • Xinjun Guo
      • Longyan, Kina
        • Har ikke rekruttert ennå
        • Longyan First Hospital
        • Ta kontakt med:
          • Wuyang Zheng
        • Hovedetterforsker:
          • Wuyang Zheng
      • Luohe, Kina
        • Rekruttering
        • Luohe Central Hospital
        • Ta kontakt med:
          • Qiaotao Xie
        • Hovedetterforsker:
          • Qiaotao Xie
      • Nanchang, Kina
        • Rekruttering
        • The Second Affiliated Hospital of Nanchang University
        • Ta kontakt med:
          • Yifei Dong
        • Hovedetterforsker:
          • Yifei Dong
      • Nanjing, Kina
        • Har ikke rekruttert ennå
        • Jiangsu Province Hospital
        • Ta kontakt med:
          • Wei Sun
        • Hovedetterforsker:
          • Wei Sun
      • Shantou, Kina
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Shantou university Medical College
        • Ta kontakt med:
          • Youren Chen
        • Hovedetterforsker:
          • Youren Chen
      • Taiyuan, Kina
        • Har ikke rekruttert ennå
        • First Hospital of Shanxi Medical University
        • Ta kontakt med:
          • Juyan Zhang
        • Hovedetterforsker:
          • Juyan zhang
      • Tianjin, Kina
        • Rekruttering
        • Tianjin Kanghui Hospital
        • Hovedetterforsker:
          • Ning Yang
        • Ta kontakt med:
          • Ning Yang
      • Wuhan, Kina
        • Har ikke rekruttert ennå
        • Renmin Hospital of Wuhan University
        • Ta kontakt med:
          • Hongxin Xu
        • Hovedetterforsker:
          • Hongxin Xu
      • Xiamen, Kina
        • Rekruttering
        • The First Affiliated Hospital of Xiamen University
        • Ta kontakt med:
          • Zhengrong Huang
        • Hovedetterforsker:
          • Zhengrong Huang

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Control group
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Legemiddel: Placebo
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Eksperimentell: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in office SBP at Week 8
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in office DBP at Week 8
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean daytime ambulatory SBP/DBP at Week 8
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 8 weeks from treatment initiation.
8 weeks from treatment initiation.
Change from baseline in total cholesterol concentration at Week 8.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Anzhen Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KS2025249

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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