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Набор скоро начнётся NCT06901570

Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease

Фаза IV С лечением Coronary Microvascular Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kuangxiong Aerosol, Placebo Drug.
Кому может быть актуально
Состояния в реестре: Coronary Microvascular Disease. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Clinical Assessment of Aromatic Wentong for Coronary Microvascular Disease Management

Обзор

Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coronary heart disease, especially those with chest pain as their main symptom. Unfortunately, there are no effective treatments available for these patients, and symptoms like chest tightness and persistent pain greatly affect their quality of life. Traditional Chinese Medicine (TCM) suggests that the root cause of microvascular disease is blocked collateral blood vessels. Aromatic Wentong, a TCM approach, aims to improve blood flow and relieve blockages. Kuangxiong Aerosol is a Chinese patent medicine developed based on the principles of Aromatic Wentong. This study is a multicenter, randomized, double-blind, placebo-controlled trial involving 528 patients with chest pain and suspected CMD. Participants are recruited from several hospitals, including China-Japan Friendship Hospital, Fuwai Hospital, and Xiyuan Hospital. Patients are randomly divided into two groups: The intervention group receives standard guideline-recommended treatment plus Kuangxiong Aerosol. The control group receives standard treatment plus a placebo version of Kuangxiong Aerosol. The treatment lasts for 8 weeks.

Вмешательства

  • Препарат Kuangxiong Aerosol
    Patients in the intervention group will receive Kuangxiong Aerosol for eight weeks, in addition to guideline-recommended medications. The aerosol will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily.
  • Препарат Placebo Drug
    Patients in the control group will receive a placebo version of Kuangxiong Aerosol for eight weeks, alongside guideline-recommended medications. The placebo will be administered sublingually (under the tongue), with a dosage of two sprays per dose, three times daily.

Первичные конечные точки

  • Score of the Seattle Angina Questionnaire [Срок оценки: Baseline, 4 weeks, and 8 weeks]
Вторичные конечные точки (9)
  • Score of the Traditional Chinese Medicine Syndrome Score Scale [Срок оценки: Baseline, 4 weeks, and 8 weeks.]
  • Score of the Medical Outcomes Study 36-Item Short-Form Health Survey [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Levels of inflammatory factors (CRP, hs-CRP, IL-1β, IL-6) [Срок оценки: Baseline, 8 weeks]
  • Levels of vascular endothelial function markers (NO, ET-1) [Срок оценки: Baseline, 8 weeks]
  • Factors and levels of transcriptomics [Срок оценки: Baseline, 8 weeks]
  • Factors and levels of proteomics [Срок оценки: Baseline, 8 weeks]
  • Factors and levels of metabolomics [Срок оценки: Baseline, 8 weeks]
  • Myocardial contrast echocardiography [Срок оценки: Baseline, 8 weeks]
  • Major adverse cardiovascular events [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Aged between 18 and 80 years, regardless of gender.
  • Clinical symptoms of myocardial ischemia.
  • Objective evidence of myocardial ischemia, including:
  • ECG changes during chest pain episodes,
  • Stress test-induced chest pain symptoms and/or abnormal myocardial blood flow and/or abnormal cardiac wall motion with ischemic ECG changes.
  • Coronary angiography (CAG) showing >50% reduction in the diameter of the epicardial coronary artery.
  • QFR > 0.80 and AMR > 2.5 mmHg·s/cm.
  • Discontinuation of all Chinese medicine interventions for at least two weeks prior to enrollment.
  • Provision of informed consent and a signed informed consent form.

Критерии исключения

  • Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels >3 times the upper limit of normal.
  • Severe cardiac conditions, including heart failure, myocarditis, cardiomyopathy, acute pericarditis, structural heart disease.
  • Severe systemic diseases, such as severe mental illness, hematopoietic system disorders, or malignant tumors.
  • Suspected or confirmed allergy to the trial drug.
  • Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
  • Women who are pregnant, planning to become pregnant, or currently lactating.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT06901570 · 2023ZD0505705

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗