Danhong Injection in the Treatment of Unstable Angina Pectoris

A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris

The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.

Inclusion Criteria:

• Female or male inpatients.
• Age: 35 - 75 years.
• Patients with clinical diagnosis of unstable stable angina according to China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association, including one of the following conditions.
• Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in UA ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is a 6-item questionnaire including the symtoms as following: (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5.
• Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

• Patients with severe heart failure (EF<35%);
• Patients with history of infection, fever, trauma, surgery(exclude PCI) and inflammation in the past month;
• Patients with active tuberculosis or rheumatological disorders;
• Patients with renal dysfunction (Male: CCr>2.5mg/dl; Female: CCr>2.0mg/dl);
• Patients with liver dysfunction (any value of serum aminotransferase more than triple normal value);
• Patients with history of hematopoietic system diseases;
• Patients with mental disorder;
• Patients with history of drug-induced bleeding or history of bleeding caused by warfarin;
• Patients with malignant tumor;
• Patients with history of organ transplant;
• Woman with pregnancy, lactation or positive result of pregnancy test;
• Patients who is participating in other trials or has been participated in other trials in recent 3 months;
• Patients who were unable to participate in the study as judged by investigator.