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A block randomized, double-blind, parallel-group, multi-center clinical study to evaluate the efficacy and safety of Wufuxinnaoqing Soft Capsule in treatment of chronic stable angina (blood stasis syndrome)

A Multicenter, Randomized, Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule in Treatment of Chronic Stable Angina (Blood Stasis Syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005158
Enrollment
Unknown
Registered
2014-08-27
Start date
2012-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic Stable Angina

Interventions

the treatment group:Wufuxinnaoqing Soft Capsule
Control:Placebo

Sponsors

China Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
34 Years to 71 Years

Inclusion criteria

Inclusion criteria: 1. To be met any of following diagnostic standard of coronary heart disease: (1) with a clear history of old myocardial infarction, or history of PCI, or history of bypass; (2) coronary angiography results suggested that at least one coronary artery was stenosed and the stenosis was more than 50% or coronary CTA suggested a stenosis of more than 50%; (3) diagnosed of myocardial ischemia of coronary artery disease by radionuclide; (4) submaximal exercise treadmill ECG test was positive; (5) angina attacks with typical ischemic ECG; 2. Patients to be complicated with blood stasis syndrome differentiation criteria in Chinese medicine; 3. meeting the diagnostic criteria for chronic stable angina, with a history of angina pectoris longer than 1 month; 4. attacks of angina more than 2 times/week and less than 5 times/day; 5. CCS angina classification grade I-III; 6. continuous use of the current drugs for treatment of angina for a month or more; 7. between the ages of 30 to 70 years; 8. research program approved by each member of ethics committee and signed the clinical research ethic documents.Patients were informed, and voluntarily signed the informed consent; 9. at the end of the import period meeting the above standards.

Exclusion criteria

Exclusion criteria: 1. with severe heart diseases (unstable angina, acute myocardial infarction occurred within six months, etc), severe cardiopulmonary dysfunction (heart function grade III or IV, severe lung abnormalities); 2. with hypertension beyond control (systolic blood pressure higher than 160mmHg or diastolic blood pressure higher than 100mmHg after treatment); 3. combining severe liver and kidney dysfunction, combining severe primary diseases such as hematopoietic system diseases, or combining mental diseases; 4. within three months after the intervention; 5. patients who had regularly used beta-blockers in past month and could not stop the drugs by the judgment of researchers; 6. patients with pacemakers; 7. during pregnancy, lactation or pregnancy planner; 8. patients who had participated in other clinical researches within the past three months; 9. allergies or known allergy to the experimental drug; 10. people who researchers believed should not participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Angina symptom score;

Secondary

MeasureTime frame
Quantified score of Chinese medicine syndrome;

Countries

China

Contacts

Public ContactXU Feng-qin
doctorxu@aliyun.com+86 18800021979

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 18, 2026