Ischemic Heart DiseasePhase 2NCT07478328
Chaigui Longmu Ejiao Paste for Ischemic Heart Disease
A Phase 2 study testing Standard Western medicine treatment + Chaigui Longmu Ejiao Paste in people with Ischemic Heart Disease, run by Longhua Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, Xuhui District
Lili Yang, Ph.D, 13816867654, lhtcmkyc@163.com
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Standard Western medicine treatment + Chaigui Longmu Ejiao Paste, Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Western medicine treatment + Chaigui Longmu Ejiao PasteDrug
15 g orally twice daily
Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without EjiaoDrug
15 g orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Standard Western medicine treatment + Chaigui Longmu Ejiao Paste | Experimental | 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. Receives: Drug: Standard Western medicine treatment + Chaigui Longmu Ejiao Paste |
| Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao | Placebo comparator | 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. Receives: Drug: Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weekly reduction in angina attack frequency
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).
Measured: Baseline to week 8
Secondary outcomes (8)
Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores
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).
Measured: Baseline, Week 4, and Week 8
Average Weekly Nitroglycerin Consumption
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.
Measured: Week 4, and Week 8
Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score
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.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score
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.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score
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.
Measured: Baseline, Week 4, and Week 8
Change From Baseline in SF-36 Physical Component Summary (PCS) Score
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.
Measured: Baseline, Week 4, and Week 8
Change From Baseline in SF-36 Mental Component Summary (MCS) Score
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.
Measured: Baseline, Week 4, and Week 8
Incidence of Major Adverse Cardiovascular Events (MACE) Within 8 Weeks of Treatment
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.
Measured: From randomization (baseline) through Week 8 (end of treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start8 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longhua Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, DongE E Jiao Coporation Limited
- Responsible party
- Principal investigator, Suyun Yuan, Longhua Hospital
- Investigators
- Su yun Yuan, Ph.D, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478328
- Sponsor's protocol ID
- LH-CGLMEJG-001
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07478328
- Acronym / sponsor ID
- LH-CGLMEJG-001
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Longhua HospitalUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, DongE E Jiao Coporation Limited
- Study start
- 8 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Western medicine treatment + Chaigui Longmu Ejiao Paste | Experimental | Drug: Standard Western medicine treatment + Chaigui Longmu Ejiao PasteAll 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. |
| Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao | Placebo comparator | Drug: Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without EjiaoAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Western medicine treatment + Chaigui Longmu Ejiao Paste15 g orally twice daily | Drug | Standard Western medicine treatment + Chaigui Longmu Ejiao Paste |
| Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao15 g orally twice daily | Drug | Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao |
Primary outcome
Average weekly reduction in angina attack frequency
Time frame: 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).
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Su yun Yuan, Ph.D principal investigator
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Western medicine treatment + Chaigui Longmu Ejiao Paste in people with Ischemic Heart Disease, run by Longhua Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia hong Jin, Ph.D (17321231717 ext. 021-64385700, 370708790@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average weekly reduction in angina attack frequency (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.