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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 base
• Препарат 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.

Первичные конечные точки

• Incidence Rate of Major Adverse Cardiovascular Events (MACE) [Срок оценки: Within 48 weeks after randomization]

Вторичные конечные точки (8)

• Traditional Chinese Medicine Syndrome Score [Срок оценки: Baseline (day 0), week 6, week 12, week 24, week 36, week 48]
• Echocardiographic Parameters of Cardiac Structure and Function [Срок оценки: Baseline, week 12]
• 24-Hour Holter Monitoring Parameters [Срок оценки: Baseline, week 12]
• Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Срок оценки: Baseline, week 6, week 12, week 24, week 36, week 48]
• Creatine Kinase-Myocardial Band (CK-MB) [Срок оценки: Baseline, week 12]
• Serum Lipid Profile [Срок оценки: Baseline, week 12]
• Fasting Glucose [Срок оценки: 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. [Срок оценки: Baseline, week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07616544 · ZSLL-KY-2026-028-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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