Chaigui Longmu Ejiao Paste for Ischemic Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Western medicine treatment + Chaigui Longmu Ejiao Paste, Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao.
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind Clinical Trial of Chaigui Longmu Ejiao Paste in the Treatment of Ischemic Heart Disease With Internal and External Controls
Overview
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
- Drug Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
15 g orally twice daily - Drug Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
15 g orally twice daily
Primary outcome measures
- Average weekly reduction in angina attack frequency [Time frame: Baseline to week 8]
Secondary outcome measures (8)
- Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores [Time frame: Baseline, Week 4, and Week 8]
- Average Weekly Nitroglycerin Consumption [Time frame: Week 4, and Week 8]
- Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score [Time frame: Baseline, Week 4, and Week 8]
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score [Time frame: Baseline, Week 4, and Week 8]
- Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score [Time frame: Baseline, Week 4, and Week 8]
- Change From Baseline in SF-36 Physical Component Summary (PCS) Score [Time frame: Baseline, Week 4, and Week 8]
- Change From Baseline in SF-36 Mental Component Summary (MCS) Score [Time frame: Baseline, Week 4, and Week 8]
- Incidence of Major Adverse Cardiovascular Events (MACE) Within 8 Weeks of Treatment [Time frame: From randomization (baseline) through Week 8 (end of treatment period)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai
Identifiers
NCT: NCT07478328 · LH-CGLMEJG-001