Danhong Injection in the Treatment of Unstable Angina Pectoris
- Conditions
- Unstable Angina Pectoris
- Interventions
- Drug: Danhong injectionOther: Standard medical careDrug: Placebo
- Registration Number
- NCT02007187
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief Summary
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Danhong injection Danhong injection Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days. Placebo Standard medical care Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days. Danhong injection Standard medical care Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days. Placebo Placebo Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
- Primary Outcome Measures
Name Time Method Change from baseline of the Quantification score of angina pectoris at Day 7 Day 7 Quantification score of angina pectoris is a 4-item questionnaire that quantifies the frequency of angina, the duration of angina at every attack, the severity of angina and the use of nitroglycerin in a week. Scores range from 0 to 24; higher scores indicate worse health status.
- Secondary Outcome Measures
Name Time Method Use of Short-acting Nitrates Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 Change in the electrocardiogram (ECG) Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 ECG will be done five times every day, when 5-10 min before use of nitrates or Danhong injection, 5-10 min after use of nitrates or Danhong injection, at the time 22:00. If there is an angina attack, an additional ECG should be done when the angina attacks.
The proportion of patients who are undergoing PCI Day 7, Day 28 Change in Seattle Angina Questionnaire Day 0, Day 28 Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.
Incidence of adverse events (including serious adverse events) in 28 days 28 days Total score of symptoms questionnaire of TCM Day 0, Day 7 The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.
Trial Locations
- Locations (9)
Zhengzhou No.7 People's Hospital
🇨🇳Zhengzhou, Henan, China
Xuanwu Hospital
🇨🇳Beijing, Beijing, China
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Affiliated Hospital to Changchun University of Chinese Medicine
🇨🇳Changchun, Jilin, China
First Teaching Hospital of Tianjin University of T.C.M.
🇨🇳Tianjin, Tianjin, China
Hospital 463 of P.L.A.
🇨🇳Shenyang, Liaoning, China