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

2026년 5월 29일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

350

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Control group
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
의약품: Placebo
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
실험적: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change from baseline in office SBP at Week 8
기간: 8 weeks from treatment initiation.
8 weeks from treatment initiation.

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Anzhen Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 15일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 7일

QC 기준을 충족하는 최초 제출

2026년 5월 21일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KS2025249

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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