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Evaluation of the efficacy and safety of Shixiang Tongxin Pills in the treatment of coronary microvascular disease - a multicenter randomized double-blind placebo-controlled study

Evaluation of the efficacy and safety of Shixiang Tongxin Pills in the treatment of coronary microvascular disease - a multicenter randomized double-blind placebo-controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000414
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

coronary microvascular disease

Interventions

Placebo Group:Placebo
Experimental Group:Shexiang Tongxin dripping pills

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: CMVD (microvascular angina) without obstructive coronary artery disease: 1) Symptoms of myocardial ischemia: 1) Typical symptoms: angina on exertion/rest; 2) other atypical symptoms such as dyspnea pain between shoulder bones etc.; 2) Exclusion of obstructive CAD: coronary CTA or invasive coronary angiography showed epicardial coronary artery diameter stenosis 0.8; 3) Objective evidence of myocardial ischemia: 1) ischemic changes on ECG during the onset of chest pain; 2) Stress test induced chest pain and/or ischemic ECG changes with/or without wall motion abnormalities and/or myocardial perfusion abnormalities. 4) Evidence of impaired coronary microvascular function: coronary flow reserve (CFR)<2.0 2: Angina pectoris occurred more than 2 times per week 3: age ranged from 18 to 80 years 4: Patients volunteered for follow-up and signed informed consent

Exclusion criteria

Exclusion criteria: 1: Allergic to Shexiang Tongxin dripping pills or its components (asarum oil sandalwood oil galangal oil long pepper oil borneol) and any component of medicines; 2: angina caused by non-cardiac causes (gastrointestinal diseases musculoskeletal disorders etc.); 3: persistent severe angina pectoris (CCS ?); 4: Severe ST-segment depression after daily activities; 5: LVEF<30% was detected by echocardiography in the past; Or refractory heart failure or cardiogenic shock; 6: patients undergoing CABG or PCI during the trial; 7: glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2; 8: have significant liver disease or ALT or AST higher than 3 times the upper limit of normal 9: any other serious disease or condition such as malignancy; 10: uncontrolled severe hypertension and arrhythmia; 11: had participated in another clinical study or had undergone randomization in the study within 30 days before enrollment; 12: pregnant women or women planning to become pregnant; 13: any other clinical condition that would endanger the safety of the patient or may prevent the subject from complying with the trial protocol; 14: Patients deemed by the investigator to be ineligible for the study 15: severe valvular heart disease and cardiomyopathy; 16: allergy to ultrasound contrast agents; 17: absolute contraindications to loading drugs.

Design outcomes

Primary

MeasureTime frame
MBF;

Secondary

MeasureTime frame
Blood lipids;ß;wall motion;CO;A;SDS;SV;TCM symptom rating scale;E/A;LVFS;CI;SAS;CRP;EF;EQ-5D;FS;LVEF;HCY;Assessments OF SAFETY;SAQ;VAS;

Countries

China

Contacts

Public ContactLei Wang

Guangdong Provincial Hospital of Traditional Chinese Medicine

Dr.wanglei@gzucm.edu.cn13724078381

Outcome results

None listed

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