Danhong Injection in the Treatment of Chronic Stable Angina

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients

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Detailed Description

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Conditions

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Chronic Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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 hours.

Group Type EXPERIMENTAL

Danhong injection

Intervention Type DRUG

A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower

Standard medical care

Intervention Type OTHER

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

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 hours.

Group Type PLACEBO_COMPARATOR

Standard medical care

Intervention Type OTHER

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Placebo

Intervention Type DRUG

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.

Interventions

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Danhong injection

A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower

Intervention Type DRUG

Standard medical care

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female or male inpatients.
* Age: 18 - 70 years.
* Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in angina ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined 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.
* Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria

* Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
* Woman who disagree with contraception during treatment period
* Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
* Patients who were angina-free during the run-in period without taking any drug.
* Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
* Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
* Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
* Patients with history of hematopoietic system diseases.
* Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
* Patients who is participating in other trials or has been participated in other trials in recent 3 months.
* Patients with history of allergy or suspected allergic to the drug.
* Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
* Patients with mental disorder.
* Patients who were unable to participate in the study as judged by investigator.
* Patients who were family members or relatives of the research center staffs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhong Wang

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhong Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Yun-dai Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital(301 Hospital)

Yong-yan Wang, Professor

Role: STUDY_CHAIR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Xiao-xi Du, Professor

Role: STUDY_DIRECTOR

China Food and Drug Administration

Locations

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