Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization
27. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
164
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Liu Qiang, PhD
- Telefonní číslo: +86 13588121905
- E-mail: 19981011@zcmu.edu.cn
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Komparátor placeba: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence Rate of Major Adverse Cardiovascular Events (MACE)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Traditional Chinese Medicine Syndrome Score
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline, week 12
|
Serum CK-MB measured from fasting blood samples.
|
Baseline, week 12
|
|
Serum Lipid Profile
Časové okno: Baseline, week 12
|
Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.
|
Baseline, week 12
|
|
Fasting Glucose
Časové okno: 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.
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Red blood cell count
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
30. června 2028
Dokončení studie (Odhadovaný)
31. prosince 2028
Termíny zápisu do studia
První předloženo
14. května 2026
První předloženo, které splnilo kritéria kontroly kvality
27. května 2026
První zveřejněno (Aktuální)
1. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ZSLL-KY-2026-028-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.
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Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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