Danhong Injection in the Treatment of Unstable Angina Pectoris

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Collaborator: China Food and Drug Administration

Criteria

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.