Randomized, double-blind, placebo-controlled, multicenter clinical trial of Shexiang Baoxin Pill in the treatment of ischemic patients with non obstructive coronary artery disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080152

Enrollment

Unknown

Registered

2024-01-22

Start date

2023-08-25

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

Ischemia with non obstructive coronary artery disease

Interventions

treatment group:Shexiang Baoxin Pill in combination with conventional Western medical treatment

placebo group:placebo in combination with conventional Western medical treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age>18 years old; 2) Patients with symptoms related to myocardial ischemia, with coronary angiography or coronary CTA indicating that the diameter of each coronary artery stenosis is less than 50%; 3) DSPECT examination showed abnormal myocardial perfusion under load, with CFR<2.5; 4) The patient signs an informed consent form;

Exclusion criteria

Exclusion criteria: 1) Patients with severe heart failure who require intravenous administration of vasoactive drugs; 2) Uncontrolled blood pressure (SBP = 180 mmHg or DBP = 110 mmHg); 3) Patients with malignant arrhythmia, atrial fibrillation, and frequent premature beats; 4) Patients with concomitant heart valve disease or congenital heart disease who have not undergone surgical or interventional treatment to correct their deformities; 5) Patients with liver and kidney dysfunction, ALT exceeding 2 times the normal upper limit, and/or severe renal function impairment (defined as creatinine>100 or eGFR<30); 6) Concomitant with other causes of precordial pain (such as cholecystitis or gallstones, ulcer disease, reflux esophagitis or hiatal hernia, neurasthenia, etc.); 7) Previous history of myocardial infarction (MI) or percutaneous coronary intervention (PCI); 8) Myocardial bridge patients; 9) Individuals with a history of multiple drug allergies, allergic diseases, or allergic constitutions; 10) Alcoholics or drug users; 11) Patients with malignant tumors who are undergoing radiotherapy or chemotherapy; 12) Those who have experienced severe trauma or undergone major surgical procedures within the past month; 13) Pregnant or preparing pregnant or lactating women; 14) Those who have participated in other drug trials within 3 months; 15) Researchers believe that it is not suitable.

Design outcomes

Primary

Measure	Time frame
coronary flow reserve;	—

Secondary

Measure	Time frame
MBF, PFR, EDV, ESV, LVEF, Phase analysis indicators;Seattle Angina Questionnaire, SAQ;Changes in cardiac function;6-minute walking test;	—

Countries

China

Contacts

Public ContactPing Xie

Gansu Provincial Hospital

pingxie66@163.com+86 139 1976 1522

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026