Chaigui Longmu Ejiao Paste for Ischemic Heart Disease

Официальное название

A Randomized, Double-Blind Clinical Trial of Chaigui Longmu Ejiao Paste in the Treatment of Ischemic Heart Disease With Internal and External Controls

Обзор

This study explores whether Chaigui Longmu Ejiao Paste can reduce the average weekly number of angina attacks in patients with ischemic heart disease after 8 weeks of treatment, using Chaigui Longmu Paste without Ejiao as a parallel control and incorporating a synthesized external control.

Подробное описание

Overall Study Design: This is a randomized, double-blind clinical trial with internal and external controls.

Trial Procedure: The study includes a screening/baseline period, an 8-week treatment period, and a 4-week follow-up period. The end-of-study/end-of-treatment visit (EOS/EOT) is performed at 12 weeks after treatment initiation.

Randomization and Blinding: Block randomization is applied, with a 1:1 allocation ratio across groups. The trial is double-blinded.

External Control: Literature data (external control derived from published literature).

Data Collection: Data are collected using an Electronic Data Capture (EDC) system in combination with an electronic Patient-Reported Outcomes (ePRO) system.

Вмешательства

• Препарат Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
  15 g orally twice daily
• Препарат Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
  15 g orally twice daily

Первичные конечные точки

• Average weekly reduction in angina attack frequency [Срок оценки: Baseline to week 8]

Вторичные конечные точки (8)

• Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores [Срок оценки: Baseline, Week 4, and Week 8]
• Average Weekly Nitroglycerin Consumption [Срок оценки: Week 4, and Week 8]
• Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score [Срок оценки: Baseline, Week 4, and Week 8]
• Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score [Срок оценки: Baseline, Week 4, and Week 8]
• Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score [Срок оценки: Baseline, Week 4, and Week 8]
• Change From Baseline in SF-36 Physical Component Summary (PCS) Score [Срок оценки: Baseline, Week 4, and Week 8]
• Change From Baseline in SF-36 Mental Component Summary (MCS) Score [Срок оценки: Baseline, Week 4, and Week 8]
• Incidence of Major Adverse Cardiovascular Events (MACE) Within 8 Weeks of Treatment [Срок оценки: From randomization (baseline) through Week 8 (end of treatment period)]

Критерии участия

Критерии включения

• Age 18-75 years, both sexes eligible;
• Meets the diagnostic criteria for stable angina pectoris in ischemic heart disease (IHD), with stable condition for ≥4 weeks;
• Has received standard Western medical treatment (including but not limited to antiplatelet agents, lipid-modifying/stabilizing plaque therapy, β-blockers, etc.) for at least 4 weeks, with stable dosages;
• Meets the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria of "thoracic yang deficiency with heart vessel stasis" (or "chest yang insufficiency with heart meridian blood stasis"), with primary symptoms: chest oppression/pain, palpitations; at least 2 secondary symptoms: insomnia, aversion to cold, spontaneous sweating, irritability or restlessness; supported by tongue and pulse findings;
• Has signed the informed consent form and is willing to participate voluntarily in the study.

Критерии исключения

• Acute coronary syndrome or patients requiring emergency revascularization;
• Use of traditional Chinese medicine (TCM) or Chinese patent medicines with therapeutic effects on ischemic heart disease within the past 2 weeks;
• Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after treatment);
• Severe heart failure (NYHA functional class IV), uncontrolled malignant arrhythmias, cardiogenic shock; severe cerebrovascular diseases; active or recurrent digestive system ulcers or other diseases with bleeding risk; other severe digestive system diseases; complicated with malignant tumors, hematological disorders, or other severe or progressive systemic diseases; complicated with other mental disorders that render the patient unable or unwilling to cooperate;
• Severe hepatic or renal impairment (ALT/AST > 3 × upper limit of normal, or creatinine > 1.5 × upper limit of normal);
• Known allergy to any component of the study formula;
• Women who are pregnant, lactating, or planning pregnancy;
• Patients who have participated in other clinical trials within the past 3 months;
• Patients deemed by the investigator to be unsuitable for participation in the clinical trial.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Шанхай

Идентификаторы

NCT: NCT07478328 · LH-CGLMEJG-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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