Chaigui Longmu Ejiao Paste for Ischemic Heart Disease
ConditionIschemic Heart Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLonghua Hospital
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
- Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Longhua Hospital
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator
DongE E Jiao Coporation Limited
Collaborator
Source ClinicalTrials.gov