Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization
2026년 5월 27일 업데이트: Liu Qiang
- Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;
- Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;
- Demonstrate the advantages of traditional Chinese medicine rehabilitation treatment in the postoperative management of coronary revascularization surgery and provide high-level evidence-based medical evidence for the development of traditional Chinese medicine rehabilitation treatment plans.
연구 개요
상태
아직 모집하지 않음
상세 설명
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial.
Patients who have undergone coronary revascularization will be randomly assigned to receive either Qidan Xiaohe Granules or a matching placebo, in addition to standard medical therapy.
The treatment period lasts 12 weeks, and participants will be followed up for a total of 48 weeks.
The main goal is to see whether adding the Chinese herbal medicine reduces the occurrence of major adverse cardiovascular events such as death, heart attack, recurrent chest pain, or repeat revascularization.
Secondary goals include improvements in heart function, quality of life, and traditional Chinese medicine symptom scores.
Safety will be monitored throughout the study.
The results will help determine whether this herbal formula can be recommended as an effective and safe rehabilitation treatment for patients after coronary revascularization.
연구 유형
중재적
등록 (추정된)
164
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Liu Qiang, PhD
- 전화번호: +86 13588121905
- 이메일: 19981011@zcmu.edu.cn
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:
- Age: 18-80 years old;
- no gender limitation;
- Meets the diagnostic criteria for coronary heart disease;
- Accepts effective PCI procedure;
- Voluntarily participates and signs a written informed consent form.
Exclusion Criteria:
- Severe hepatic and/or renal insufficiency
- Severe electrolyte disorders
- Severe hematological diseases or malignant tumors
- Pregnant or breastfeeding women
- Patients with mental illness
- Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally
- Planning to undergo another revascularization surgery in the near future
- Other severe cardiovascular diseases (e.g., uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block without a pacemaker implanted, acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, acute aortic dissection, etc.)
- Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion)
- Explicit exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)
- Participants in other interventional clinical trials within the past month
- Allergy to known components of the investigational drug (Qidan Xiaohe Granules)
- Other conditions deemed unsuitable for participation in the trial by the investigator
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental Group
Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy , statins, beta-blockers, ACEI/ARB, and other medications as clinically indicated.
In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks.
The granules are dissolved in warm water before administration.
The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline.
The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.
|
Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy, statins, beta-blockers, ACEI/ARB, and other medications as clinically indicated.
In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks.
The granules are dissolved in warm water before administration.
The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline.
The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.
|
|
위약 비교기: Control Group
Participants in this arm receive the same standard medical therapy as the experimental group.
In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks.
The placebo has no pharmacological activity related to the investigational product.
The treatment and follow-up schedule are identical to the experimental group.
|
Participants in this arm receive the same standard medical therapy as the experimental group.
In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks.
The placebo has no pharmacological activity related to the investigational product.
The treatment and follow-up schedule are identical to the experimental group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence Rate of Major Adverse Cardiovascular Events (MACE)
기간: Within 48 weeks after randomization
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MACE is defined as a composite endpoint including the following seven events: (1) all-cause death; (2) subacute stent thrombosis; (3) peri-procedural myocardial infarction; (4) recurrent myocardial infarction; (5) recurrent unstable angina; (6) repeat revascularization ; and (7) rehospitalization due to angina or heart failure.
All events are adjudicated by an independent Clinical Endpoint Committee blinded to treatment allocation, based on source documents.
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Within 48 weeks after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Traditional Chinese Medicine Syndrome Score
기간: Baseline (day 0), week 6, week 12, week 24, week 36, week 48
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The scale evaluates 14 symptoms.
Each symptom is scored as 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
Tongue appearance (color, coating) and pulse pattern are also recorded.
With higher scores indicating more severe TCM syndrome.
Assessments are performed by two trained TCM physicians independently; discrepancies are resolved by a third senior physician.
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Baseline (day 0), week 6, week 12, week 24, week 36, week 48
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Echocardiographic Parameters of Cardiac Structure and Function
기간: Baseline, week 12
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Echocardiography is performed using a standardized protocol at each participating site.
Parameters measured include: (1) Left ventricular ejection fraction ; (2) Left ventricular end-diastolic diameter (LVEDD); (3) Left ventricular end-systolic diameter (LVESD); (4) Left ventricular posterior wall thickness (LVPW); (5) Interventricular septal thickness (IVS); (6) E/A ratio (peak velocity of early to late diastolic filling); (7) Average E/e' ratio (mitral inflow to annular velocity).
All measurements are performed by certified sonographers following a centralized training program.
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Baseline, week 12
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24-Hour Holter Monitoring Parameters
기간: Baseline, week 12
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Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.
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Baseline, week 12
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Minnesota Living with Heart Failure Questionnaire (MLHFQ)
기간: Baseline, week 6, week 12, week 24, week 36, week 48
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The MLHFQ is a 21-item, self-administered questionnaire that assesses the impact of heart failure on health-related quality of life.
Each item is scored from 0 (no impact) to 5 (very severe impact).
With higher scores indicating worse quality of life.
The questionnaire is administered in the validated Chinese version.
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Baseline, week 6, week 12, week 24, week 36, week 48
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Creatine Kinase-Myocardial Band (CK-MB)
기간: Baseline, week 12
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Serum CK-MB measured from fasting blood samples.
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Baseline, week 12
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Serum Lipid Profile
기간: Baseline, week 12
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Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
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Baseline, week 12
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Fasting Glucose
기간: Baseline, week 12
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Fasting blood glucose measured using standard laboratory methods.
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Baseline, week 12
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Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.
기간: Baseline, week 12
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Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.
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Baseline, week 12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Red blood cell count
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.
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Baseline, week 12
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Haemoglobin concentration
기간: Baseline, week 12
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Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
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Baseline, week 12
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White blood cell count
기간: Baseline, week 12
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Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
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Baseline, week 12
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Platelet count
기간: Baseline, week 12
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Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
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Baseline, week 12
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Haematocrit
기간: Baseline, week 12
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Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
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Baseline, week 12
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Alanine transaminase
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Aspartate transaminase
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Alkaline phosphatase
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Potassium
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Sodium
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Total bilirubin
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Blood urea nitrogen
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Creatinine
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Uric acid
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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Homocysteine
기간: Baseline, week 12
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As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
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Baseline, week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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 7월 1일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 14일
QC 기준을 충족하는 최초 제출
2026년 5월 27일
처음 게시됨 (실제)
2026년 6월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 27일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ZSLL-KY-2026-028-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.
약물 및 장치 정보, 연구 문서
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아니
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아니
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