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A randomized, double-blind, placebo parallel controlled clinical trial to evaluate the safety and efficacy of Yang Xin Granules in subjects with the patients with chronic stable angina

A randomized, double-blind, placebo parallel controlled clinical trial to evaluate the safety and efficacy of Yang Xin Granules in subjects with the patients with chronic stable angina

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004758
Enrollment
Unknown
Registered
2014-06-02
Start date
2014-12-01
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 treated group:Standardization of western medicine treatment plan
Control:Standardization of western medicine treatment plan and placebo

Sponsors

First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients between 40 to 75 years old man or woman is allowed; 2. Patients with a diagnosis of chronic stable angina; 3. Patients with syndrome of qi and blood deficiency in TCM; 4. Stable exertional angina pectoris (grade I, II, and III); 5.Those who signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a diagnosis of unstable angina pectoris or with a history of myocardial infarction within 3 months; 2. Patients diagnosed with acute myocardial infarction and chest pain of rheumatic heart disease, dilated cardiomyopathy, severe neurosis, menopausal syndrome, hyperthyreosis, anemia, cervical spondylosis, Bilio-Cardiac Syndrome, gastroesophageal reflux, esophagus hiatal hernia, aortic dissection origin and so forth which are considered by researchers to affect clinical evaluation; 3. Patients with still high blood pressure after concurrent hypertension treated via drugs (systolic pressure higher than 180mmHg or diastolic blood pressure higher than 110mmHg), severe cardiopulmonary insufficiency, severe arrhythmia, concurrent serious primary diseases in liver, kidney, of which blood ALT, AST higher than 1.5 times normal limit and serum creatinine (Cr) higher than 1.5 times normal limit; 4. Patients did CABG or PCI in past 6 months; 5. Patients with mental disorder; 6. Patients who are pregnant or nursing. Patients who intend to become pregnant during the trial period; 7. Patients who are allergic to the trial drug or with allergic constitution, patients who tends to allergic to the trial drug; 8. Patients who participate in other clinical trials within 1 month or intend to participate in other clinical trials; 9. Patients do not suit for this trial with doctors' judgement; 10. A patient must not be a member or a family member of the personnel of the investigational or SPONSOR staff directly involved with this trial.

Design outcomes

Primary

MeasureTime frame
The weekly angina frequency;Seattle Angina Questionnaire (SAQ);

Secondary

MeasureTime frame
TCM syndrome treatment efficacy;nitroglycerin withdrawal or reduction rate;ECG efficacy evaluation;The incidence of total cardiovascular events in 6 months;

Countries

China

Contacts

Public ContactYabin Zhou

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

zhouyabin@hotmail.com+86 13009995859

Outcome results

None listed

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