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Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization

27. Mai 2026 aktualisiert von: Liu Qiang
  1. Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;
  2. Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;
  3. 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

164

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age: 18-80 years old;
  2. no gender limitation;
  3. Meets the diagnostic criteria for coronary heart disease;
  4. Accepts effective PCI procedure;
  5. Voluntarily participates and signs a written informed consent form.

Exclusion Criteria:

  1. Severe hepatic and/or renal insufficiency
  2. Severe electrolyte disorders
  3. Severe hematological diseases or malignant tumors
  4. Pregnant or breastfeeding women
  5. Patients with mental illness
  6. Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally
  7. Planning to undergo another revascularization surgery in the near future
  8. 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.)
  9. Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion)
  10. Explicit exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)
  11. Participants in other interventional clinical trials within the past month
  12. Allergy to known components of the investigational drug (Qidan Xiaohe Granules)
  13. Other conditions deemed unsuitable for participation in the trial by the investigator

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Qidan Xiaoke Granules + Standard Medical Therapy
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.
Placebo-Komparator: 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.
Arzneimittel: Placebo + Standard Medical Therapy
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
Zeitfenster: Within 48 weeks after randomization
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.
Within 48 weeks after randomization

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Traditional Chinese Medicine Syndrome Score
Zeitfenster: Baseline (day 0), week 6, week 12, week 24, week 36, week 48
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.
Baseline (day 0), week 6, week 12, week 24, week 36, week 48
Echocardiographic Parameters of Cardiac Structure and Function
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
24-Hour Holter Monitoring Parameters
Zeitfenster: Baseline, week 12
Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.
Baseline, week 12
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Zeitfenster: Baseline, week 6, week 12, week 24, week 36, week 48
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.
Baseline, week 6, week 12, week 24, week 36, week 48
Creatine Kinase-Myocardial Band (CK-MB)
Zeitfenster: Baseline, week 12
Serum CK-MB measured from fasting blood samples.
Baseline, week 12
Serum Lipid Profile
Zeitfenster: Baseline, week 12
Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
Baseline, week 12
Fasting Glucose
Zeitfenster: Baseline, week 12
Fasting blood glucose measured using standard laboratory methods.
Baseline, week 12
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.
Zeitfenster: Baseline, week 12
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.
Baseline, week 12

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Red blood cell count
Zeitfenster: Baseline, week 12
As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.
Baseline, week 12
Haemoglobin concentration
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
White blood cell count
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Platelet count
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Haematocrit
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Alanine transaminase
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Aspartate transaminase
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Alkaline phosphatase
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Potassium
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Sodium
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Total bilirubin
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Blood urea nitrogen
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Creatinine
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Uric acid
Zeitfenster: Baseline, week 12
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.
Baseline, week 12
Homocysteine
Zeitfenster: Baseline, week 12
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.
Baseline, week 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Liu Qiang

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

30. Juni 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ZSLL-KY-2026-028-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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