Ischemic Heart Disease
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGStandard Western medicine treatment + Chaigui Longmu Ejiao Paste
15 g orally twice daily
DRUGPlacebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
15 g orally twice daily
Sponsors
Longhua Hospital
Shanghai University of Traditional Chinese Medicine
Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine
Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine
DongE E Jiao Coporation Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators were blinded to treatment allocation using identical-appearing pastes for experimental and control groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores | Baseline, Week 4, and Week 8 | The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific, self-reported instrument that assesses health status in patients with angina due to ischemic heart disease. It measures five domains: Physical Limitation (extent of limitation in physical activity due to angina), Angina Stability (change in angina frequency over the past 4 weeks), Angina Frequency (frequency and burden of angina episodes), Treatment Satisfaction (satisfaction with angina treatment), and Disease Perception/Quality of Life (impact of angina on quality of life). Each domain is scored from 0 to 100, with higher scores indicating better health status (less limitation, fewer symptoms, greater satisfaction, better quality of life). Change = (Week 4 or Week 8 Score - Baseline Score) for each domain and the total score (overall summary score, if applicable, averaging the relevant domains). |
| Average Weekly Nitroglycerin Consumption | Week 4, and Week 8 | The average number of nitroglycerin tablets (or sublingual sprays) used per week by the participant to relieve angina symptoms. This is a key indicator of angina burden and rescue medication requirement. |
| Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score | Baseline, Week 4, and Week 8 | The TCM Syndrome Score is a composite system based on the diagnostic criteria for the pattern "Chest Yang Deficiency with Heart Vessel Stasis". It assesses severity of: * Primary symptoms (chest oppression/chest pain, palpitations) * Secondary symptoms (insomnia, aversion to cold, spontaneous sweating, irritability/restlessness of heart and mind) Tongue and pulse are observed but not scored numerically. Scoring: * Primary symptoms: 0 (absent), 2 (mild), 4 (moderate), 6 (severe) * Secondary symptoms: 0 (absent), 1 (mild), 2 (moderate), 3 (severe) Total score = sum of all symptom scores. Higher score = greater severity. Change value * score at week 4 or 8 - baseline score A lower (more negative) change value indicates greater improvement in the TCM syndrome. |
| Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score | Baseline, Week 4, and Week 8 | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered, 14-item instrument that assesses the severity of anxiety symptoms. Each item is scored from 0 (none) to 4 (severe), with a total score ranging from 0 to 56 (higher scores indicate greater anxiety severity). The scale are administered by trained clinicians. Change = (Week 4 or Week 8 total score - Baseline total score) for each scale. Negative changes indicate improvement (reduction) in anxiety symptoms. |
| Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score | Baseline, Week 4, and Week 8 | The Hamilton Depression Rating Scale (HAMD-24) is a clinician-administered 24-item scale used to assess the severity of depressive symptoms. Most items are scored on a 5-point scale (0 = absent to 4 = very severe), with some items scored on a 3-point scale (0 = absent to 2 = severe). Total score ranges from 0 to approximately 76, with higher scores indicating greater severity of depression. The scale is administered by trained clinicians. Change = (Week 4 or Week 8 total score - Baseline total score). Negative changes indicate improvement (reduction) in depressive symptoms. |
| Change From Baseline in SF-36 Physical Component Summary (PCS) Score | Baseline, Week 4, and Week 8 | The SF-36 is a validated 36-item self-reported questionnaire that assesses health-related quality of life across 8 domains (scores 0-100, higher = better). The Physical Component Summary (PCS) is a norm-based summary score derived from weighted factor analysis of the 8 domains, standardized to a general population mean of 50 and standard deviation of 10 (higher scores indicate better physical health-related quality of life). Chinese mainland adapted version (validated by Li et al., Zhejiang University, Hangzhou community norms) used. Change = (Week 4 or Week 8 PCS score - Baseline PCS score). Positive changes indicate improvement in physical health-related quality of life. Administered via self-report with guidance from study personnel. |
| Change From Baseline in SF-36 Mental Component Summary (MCS) Score | Baseline, Week 4, and Week 8 | The SF-36 is a validated 36-item self-reported questionnaire that assesses health-related quality of life across 8 domains (scores 0-100, higher = better). The Mental Component Summary (MCS) is a norm-based summary score derived from weighted factor analysis of the 8 domains, standardized to a general population mean of 50 and standard deviation of 10 (higher scores indicate better mental health-related quality of life). Chinese mainland adapted version (validated by Li et al., Zhejiang University, Hangzhou community norms) used. Change = (Week 4 or Week 8 MCS score - Baseline MCS score). Positive changes indicate improvement in mental health-related quality of life. Administered via self-report with guidance from study personnel. |
| Incidence of Major Adverse Cardiovascular Events (MACE) Within 8 Weeks of Treatment | From randomization (baseline) through Week 8 (end of treatment period) | Major Adverse Cardiovascular Events (MACE) is a composite safety endpoint defined as the occurrence of any of the following events during the 8-week treatment period: Cardiovascular death Non-fatal myocardial infarction (MI) Non-fatal stroke Hospitalization for unstable angina requiring urgent revascularization Other protocol-defined major cardiovascular events (if applicable, e.g., severe heart failure exacerbation or resuscitated cardiac arrest) The incidence rate is calculated as the proportion of participants experiencing at least one MACE event (number of participants with ≥1 event / total number of participants in the analysis population × 100%). Events are adjudicated by an independent clinical events committee (if applicable) or by the investigator based on clinical records, ECG, biomarkers, and imaging. This outcome is assessed for safety monitoring and exploratory comparison between treatment arms. |
Countries
China
Contacts
CONTACTJia hong Jin, Ph.D
PRINCIPAL_INVESTIGATORSu yun Yuan, Ph.D
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed