To evaluate the efficacy and safety of Qidong Yixin granules in the treatment of angina pectoris of coronary heart disease (CHD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ITMCTR

Registry ID

ITMCTR2026000485

Enrollment

Unknown

Registered

2026-03-09

Start date

2026-03-10

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease Angina

Interventions

Experimental Group:This study does not restrict the treatment regimens of patients. All enrolled patients will be administered Qidong Yixin granules in addition to their current treatment regimens. 5g

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 75 years, regardless of gender; (2) Meets the diagnostic criteria for angina pectoris due to coronary artery disease; (3) Angina pectoris at I to III level (CCS angina grading); (4) Voluntarily participates in the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) History of ST-segment elevation myocardial infarction within the past six months; (2) Decompensated heart failure or severe valvular disease; (3) Subjects with psychiatric disorders, alcohol abuse, or substance abuse and dependence; (4) Subjects with malignant tumors; (5) Expected lifespan less than one year; (6) Pregnant or intending to become pregnant, or breastfeeding women; (7) Currently participating or have participated in any other clinical trial within the past month; (8) Subjects deemed unsuitable to participate in this study by the investigator.

Design outcomes

Primary

Measure	Time frame
Following 3 months of treatment, the change in the Seattle Angina Questionnaire (SAQ) total score compared to baseline.;	—

Secondary

Measure	Time frame
Change in the total score of the Seattle Angina Questionnaire (SAQ) compared to baseline after 1 month of treatment.;The overall effective rate of ECG improvement after 3-month treatment;The overall effective rate of clinical symptom improvement after 1 and 3 months of treatment.;After 3 months of treatment, the average frequency of angina attacks (times/week), average duration of each pain episode (minutes/week), pain intensity (VAS score), and nitrate medication usage (tablets/week) compared to baseline changes.;The changes in scores of the Generalized Anxiety Disorder 7-item scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), and the Insomnia Severity Index (ISI) compared to baseline after 1 and 3 months of treatment.;The incidence rate of adverse cardiovascular events within 3 months (sudden cardiac death, heart failure, malignant arrhythmia, myocardial infarction).;	—

Measure

Time frame

Change in the total score of the Seattle Angina Questionnaire (SAQ) compared to baseline after 1 month of treatment.;The overall effective rate of ECG improvement after 3-month treatment;The overall effective rate of clinical symptom improvement after 1 and 3 months of treatment.;After 3 months of treatment, the average frequency of angina attacks (times/week), average duration of each pain episode (minutes/week), pain intensity (VAS score), and nitrate medication usage (tablets/week) compared to baseline changes.;The changes in scores of the Generalized Anxiety Disorder 7-item scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), and the Insomnia Severity Index (ISI) compared to baseline after 1 and 3 months of treatment.;The incidence rate of adverse cardiovascular events within 3 months (sudden cardiac death, heart failure, malignant arrhythmia, myocardial infarction).;

—

Countries

China

Contacts

Public ContactHaichang Wang

Xi'an International Medical Center Hospital

wanghccardio@icloud.com13809197632

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026