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

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

350

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: Placebo
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Anzhen Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KS2025249

Plan for individuelle deltagerdata (IPD)

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