A Randomized, Double-Blind Clinical Trial of Chaigui Longmu Ejiao Paste in the Treatment of Ischemic Heart Disease With Internal and External Controls
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Average weekly reduction in angina attack frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators were blinded to treatment allocation using identical-appearing pastes for experimental and control groups.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
All patients receive standard Western medical treatment prescribed by the attending physician in accordance with the latest clinical guidelines, including but not limited to antiplatelet agents, statins, β-blockers, ACE inhibitors/ARBs, and others.
Participants in the experimental arm received Chaigui Longmu Ejiao Paste 15 g orally twice daily (morning and evening) for 8 weeks.
干预措施: Standard Western medicine treatment + Chaigui Longmu Ejiao Paste (Drug)
Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
All patients receive standard Western medical treatment prescribed by the attending physician in accordance with the latest clinical guidelines, including but not limited to antiplatelet agents, statins, β-blockers, ACE inhibitors/ARBs, and others.
Participants received Chaigui Longmu Paste without Ejiao 15 g orally twice daily (morning and evening) for 8 weeks.
干预措施: Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao (Drug)
结局指标
主要结局
Average weekly reduction in angina attack frequency
时间窗: Baseline to week 8
The mean change in the average number of angina attacks per week from baseline to the end of the 8-week treatment period in patients with ischemic heart disease ; Recorded using electronic patient-reported outcomes (ePRO).
次要结局
- Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores(Baseline, Week 4, and Week 8)
- Average Weekly Nitroglycerin Consumption(Week 4, and Week 8)
- Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score(Baseline, Week 4, and Week 8)
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score(Baseline, Week 4, and Week 8)
- Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score(Baseline, Week 4, and Week 8)
- Change From Baseline in SF-36 Physical Component Summary (PCS) Score(Baseline, Week 4, and Week 8)
- Change From Baseline in SF-36 Mental Component Summary (MCS) Score(Baseline, Week 4, and Week 8)
- Incidence of Major Adverse Cardiovascular Events (MACE) Within 8 Weeks of Treatment(From randomization (baseline) through Week 8 (end of treatment period))
研究者
Suyun Yuan
Chief Physician
Longhua Hospital