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Evaluation of Huoxin Pill for the treatment of chronic stable angina (Qixu Xueyu symptom): a randomized, double-blind, positive drug parallel control, multi-center clinical trial

Evaluation of Huoxin Pill for the treatment of chronic stable angina (Qixu Xueyu symptom): a randomized, double-blind, positive drug parallel control, multi-center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024296
Enrollment
Unknown
Registered
2019-07-05
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

chronic stable angina (Qixu Xueyu symptom)

Interventions

treatment group:Huoxin Pill, Xuesaitong Dropping Pill Simulation Agent
Blood circulation and blood stasis control group:Xuesaitong Dropping Pill, Huoxin Pill Simulation Agent
Aromatic warming control group:Shexiang Baoxin Pill, Xuesaitong Dropping Pill Simulation Agent

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Have an objective basis for the diagnosis of coronary heart disease (in accordance with any of the following): (1) patients with a history of acute myocardial infarction for more than half a year, need to provide inpatient medical records or discharge summary; (2) patients who have had PCI or CABG for more than half a year; (3) coronary angiography or coronary CTA showed coronary stenosis of at least one major branch of the coronary artery >= 50%; (4) male patients with positive exercise test. 2 Those who meet the syndrome differentiation standard of TCM Qixu Xueyu symptom and whose score is >=8 points; 3 Aged 18 to 75 years; male or female; 4 The patient is willing to follow up and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1 Persistent severe angina (CCS grade IV); 2 In the past, severe ST-segment depression occurred during exercise test level 1; 3 In the past, cardiac computed tomography revealed a left ventricular ejection fraction (LVEF) 200 mg/dl or 11.1 mmol/L for more than two times ?within one month before the trial). (8) renal insufficiency (Cr> 1.5 times the upper limit of normal reference); (9) Patients with severe liver disease or liver dysfunction (ALT, AST or TBIL > 2 times the upper limit of normal reference); (10) Any other serious disease or condition such as a malignant tumor; (11) Have participated in another clinical study within 30 days before the selection or have received randomization of the study; (12) Pregnant women or women preparing to become pregnant; (13) The researchers judged that the patient was not suitable for the study.

Design outcomes

Secondary

MeasureTime frame
6 minute walking test;Angina severity classification;The number of angina attacks;Seattle angina scale (SAQ) score;Nitroglycerin dosage;Electrocardiogram;

Primary

MeasureTime frame
TCM syndrome integral;

Countries

China

Contacts

Public ContactZonggui Wu

Shanghai Changzheng Hospital

18810508642@163.com+86 13501828263

Outcome results

None listed

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