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A prospective, single-arm, multi-center phase IV study of Liqihuoxue diwan for chronic stable angina

A prospective, single-arm, multi-center phase IV study of Liqihuoxue diwan for chronic stable angina

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008797
Enrollment
Unknown
Registered
2016-07-07
Start date
2016-07-15
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 pectoris of coronary heart disease

Interventions

experiment group:Liqihuoxue Diwan

Sponsors

Shanghai Changzheng hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged more than 40 years old, male and female; 2. Patients diagnosed as Coronary heart disease with chronic stable angina pectoris: (1) Diagnostic criteria TRTHE GUIDELINE FOR THE DIAGNOSIS AND TREATMENT OF THE CHRONIC STABLE ANGINA promulgated in 2007 by Chinese Society of Cardiology; (2) Patients consistent with chronic stable angina pectoris and one of following Objective diagnostic evidence, as 1) A clear case history of old myocardial infarction and ST-T changes in ECG; 2) Previous?coronary arteriongraphy or CTA result indicated that at least one coronary artery stenosis and lumen stenosis >50%; 3) Previous radionuclide?studies diagnosed as coronary heart disease; 3. Not participate in other drug clinical trials in the past 4 weeks; 4. No using Chinese patent medicine preparation approved by CFDA which has Indications of coronary heart disease and /or angina pectoris in at least 2 weeks; 5. Laboratory examination in accordance with the following standards: (l) Routine blood test: HB=95g/LANC=2.0×10^9/LPLT=100×10^9/L; (2) Liver function test: STB and CB=ULN×1.5, ALT and AST=ULN×3.0; (3) Renal function test: Cr=ULN, BUN=ULN; 6. Patients sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction, unstable angina; 2. Serious cardiopulmonary dysfunction (NYHA = III), severe arrhythmia (atrial fibrillation,Paroxysmal atrial flutter, ventricular tachycardia); 3. Non coronary heart disease angina, such as aortic valve disease, aortic dissection, hypertrophy type Cardiomyopathy, hyperthyroidism, and uncontrolled hypertension (SBP = 160mmHg,DBP = 100mmHg); 4. At the same time combined with some dieases whch the investigators believe will interfere with the objective evaluation,such as severe neurosis, climacteric syndrome, cervical spondylosis, esophageal hiatal hernia, biliary and esophageal chest pain and so on; 5. Known or suspected of allergies of the study drug or allergic constitution; 6. Female who are ready to pregnant, pregnant, breast-feeding or disagree to use contraceptive measures during the medication; 7. The situations that investigators believe do not conform to the study.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
the stopping and reducing rate of Nitroglycerin Sublingual Tablets ;ECG;

Countries

China

Contacts

Public ContactDonghu Sui

Guizhou Yibai Pharmaceutical Co., Ltd.

sudonghu@sohu.com+86 18985192981

Outcome results

None listed

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