Clinical trial NCT02007187: Danhong Injection in the Treatment of Unstable Angina Pectoris
Official title: A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unstable Angina Pectoris
Keywords: Unstable Angina Pectoris
Randomized Controlled Trial
Traditional Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Food and Drug Administration
First posted: 2013-12-10
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change from baseline of the Quantification score of angina pectoris at Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Total score of symptoms questionnaire of TCM
timeFrame: Day 0, Day 7
measure: Use of Short-acting Nitrates
timeFrame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
measure: Change in the electrocardiogram (ECG)
timeFrame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
measure: The proportion of patients who are undergoing PCI
timeFrame: Day 7, Day 28
measure: Change in Seattle Angina Questionnaire
timeFrame: Day 0, Day 28
measure: Incidence of adverse events (including serious adverse events) in 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: Zhengzhou No.7 People's Hospital
state: Henan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changchun
country: China
facility: The Affiliated Hospital to Changchun University of Chinese Medicine
state: Jilin
city: Shenyang
country: China
facility: Hospital 463 of P.L.A.
state: Liaoning
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of T.C.M.
state: Tianjin
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital, Beijing
name: Xian Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Food and Drug Administration
name: Xiao-xi Du, Professor
role: STUDY_DIRECTOR
References:
citation: Chen L, Fu G, Hua Q, Zhu HY, Deng Y, Wu W, Zhao YJ, Yang XY, Yang BS, Zhou YB, Liu J, Yu YN, Chen BW, Wang X, Wang Z. Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial. J Ethnopharmacol. 2022 Feb 10;284:114794. doi: 10.1016/j.jep.2021.114794. Epub 2021 Oct 31.