Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization
2026年5月27日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
164
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Liu Qiang, PhD
- 電話番号：+86 13588121905
- メール：19981011@zcmu.edu.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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プラセボコンパレーター：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.
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence Rate of Major Adverse Cardiovascular Events (MACE)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Traditional Chinese Medicine Syndrome Score
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Red blood cell count
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月27日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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