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

27 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

164

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Komparator placebo: 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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Traditional Chinese Medicine Syndrome Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline, week 12
Serum CK-MB measured from fasting blood samples.
Baseline, week 12
Serum Lipid Profile
Ramy czasowe: Baseline, week 12
Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
Baseline, week 12
Fasting Glucose
Ramy czasowe: 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.
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Red blood cell count
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Liu Qiang

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 maja 2026

Pierwszy wysłany (Rzeczywisty)

1 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ZSLL-KY-2026-028-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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