NCT07478328

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
31mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

March 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 8, 2026

Last Update Submit

March 13, 2026

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline to week 8

Secondary Outcomes (8)

  • Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores

    Baseline, Week 4, and Week 8

  • Average Weekly Nitroglycerin Consumption

    Week 4, and Week 8

  • Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score

    Baseline, Week 4, and Week 8

  • Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score

    Baseline, Week 4, and Week 8

  • Change from Baseline in Hamilton Depression Rating Scale (HAM-D) Score

    Baseline, Week 4, and Week 8

  • +3 more secondary outcomes

Other Outcomes (29)

  • Vital Signs (Body Temperature)

    Baseline, Week 8

  • Vital Signs (Pulse Rate)

    Baseline, Week 8

  • Vital Signs (Respiratory Rate)

    Baseline, Week 8

  • +26 more other outcomes

Study Arms (2)

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.

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.

Drug: Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao

Interventions

Standard Western medicine treatment + Chaigui Longmu Ejiao PasteDRUG

15 g orally twice daily

Standard Western medicine treatment + Chaigui Longmu Ejiao Paste
Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without EjiaoDRUG

15 g orally twice daily

Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, Xuhui District, China

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

colla corii asini

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Su yun Yuan, Ph.D

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia hong Jin, Ph.D

CONTACT

17321231717370708790@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and investigators were blinded to treatment allocation using identical-appearing pastes for experimental and control groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 17, 2026

Study Start

March 8, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)