Starting soon
Phase 2
Chaigui Longmu Ejiao Paste for Ischemic Heart Disease
Condition(s) studied
Ischemic Heart Disease
Investigational drug(s) / intervention(s)
Standard Western medicine treatment + Chaigui Longmu Ejiao PastePlacebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
Standard Western medicine treatment + Chaigui Longmu Ejiao Paste: 15 g orally twice daily
Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao: 15 g orally twice daily
Study summary
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.
Eligibility
Inclusion Criteria:
1. Age 18-75 years, both sexes eligible;
2. Meets the diagnostic criteria for stable angina pectoris in ischemic heart disease (IHD), with stable condition for ≥4 weeks;
3. 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;
4. 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;
5. Has signed the informed consent form and is willing to participate voluntarily in the study.
Exclusion Criteria:
1. Acute coronary syndrome or patients requiring emergency revascularization;
2. Use of traditional Chinese medicine (TCM) or Chinese patent medicines with therapeutic effects on ischemic heart disease within the past 2 weeks;
3. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after treatment);
4. 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;
5. Severe hepatic or renal impairment (ALT/AST \> 3 × upper limit of normal, or creatinine \> 1.5 × upper limit of normal);
6. Known allergy to any component of the study formula;
7. Women who are pregnant, lactating, or planning pregnancy;
8. Patients who have participated in other clinical trials within the past 3 months;
9. Patients deemed by the investigator to be unsuitable for participation in the clinical trial.
Primary outcome measure(s)
- Average weekly reduction in angina attack frequency — 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).
Trial sites (1)
| Facility | City | Region | Status |
| Longhua Hospital Shanghai University of Traditional Chinese Medicine |
Shanghai |
Shanghai Municipality |
|
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