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Danhong Injection in the Treatment of Unstable Angina Pectoris

Primary Purpose

Unstable Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Danhong injection
Standard medical care
Placebo
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina Pectoris focused on measuring Unstable Angina Pectoris, Randomized Controlled Trial, Traditional Chinese Medicine

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu Hospital
  • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
  • The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • Zhengzhou No.7 People's Hospital
  • The First Hospital of Changsha
  • The Affiliated Hospital to Changchun University of Chinese Medicine
  • Hospital 463 of P.L.A.
  • First Teaching Hospital of Tianjin University of T.C.M.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Danhong injection

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Use of Short-acting Nitrates
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.
The proportion of patients who are undergoing PCI
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.
Incidence of adverse events (including serious adverse events) in 28 days

Full Information

First Posted
December 5, 2013
Last Updated
November 29, 2017
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
China Food and Drug Administration
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1. Study Identification

Unique Protocol Identification Number
NCT02007187
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
China Food and Drug Administration

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Angina Pectoris
Keywords
Unstable Angina Pectoris, Randomized Controlled Trial, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Danhong injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Danhong injection
Intervention Description
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Intervention Type
Other
Intervention Name(s)
Standard medical care
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of the Quantification score of angina pectoris at Day 7
Description
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.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Total score of symptoms questionnaire of TCM
Description
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.
Time Frame
Day 0, Day 7
Title
Use of Short-acting Nitrates
Time Frame
Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
Title
Change in the electrocardiogram (ECG)
Description
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.
Time Frame
Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
Title
The proportion of patients who are undergoing PCI
Time Frame
Day 7, Day 28
Title
Change in Seattle Angina Questionnaire
Description
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.
Time Frame
Day 0, Day 28
Title
Incidence of adverse events (including serious adverse events) in 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Wang, M.D., Ph.D.
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xian Wang, M.D.
Organizational Affiliation
Dongzhimen Hospital, Beijing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiao-xi Du, Professor
Organizational Affiliation
China Food and Drug Administration
Official's Role
Study Director
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Facility Name
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Zhengzhou No.7 People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The Affiliated Hospital to Changchun University of Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Hospital 463 of P.L.A.
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110046
Country
China
Facility Name
First Teaching Hospital of Tianjin University of T.C.M.
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34732357
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.
Results Reference
derived

Learn more about this trial

Danhong Injection in the Treatment of Unstable Angina Pectoris

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