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.

Study Overview

• Status: Completed
• Conditions: Unstable Angina Pectoris
• Intervention / Treatment: Drug: Danhong injection; Drug: Placebo; Other: Standard medical care

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150040
      • The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • Henan
    • Zhengzhou, Henan, China, 450006
      • zhengzhou No.7 people's Hospital
  • Hunan
    • Changsha, Hunan, China, 410005
      • The First Hospital of ChangSha
  • Jilin
    • Changchun, Jilin, China, 130021
      • The Affiliated Hospital To Changchun University of Chinese Medicine
  • Liaoning
    • Shenyang, Liaoning, China, 110046
      • Hospital 463 of P.L.A.
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • First Teaching Hospital of Tianjin University of T.C.M.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Danhong injection; A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower; Other: Standard medical care; Standard medical care is in accordance with 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
PLACEBO_COMPARATOR: 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.	Drug: Placebo; 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.; Other: Standard medical care; Standard medical care is in accordance with 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of the Quantification score of angina pectoris at 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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of symptoms questionnaire of TCM	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.	Day 0, Day 7
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)	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.	Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
The proportion of patients who are undergoing PCI		Day 7, Day 28
Change in Seattle Angina Questionnaire	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.	Day 0, Day 28
Incidence of adverse events (including serious adverse events) in 28 days		28 days

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: China Food and Drug Administration
• Investigators: Principal Investigator: Zhong Wang, M.D., Ph.D., Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences; Principal Investigator: Xian Wang, M.D., Dongzhimen Hospital, Beijing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (ESTIMATE): December 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Traditional Chinese Medicine; Unstable Angina Pectoris
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: 2011ZX09304-07V1.2