Danhong Injection in the Treatment of Unstable Angina Pectoris

NCT02007187 | Completed Phase 4 DMC

• 1 other identifier: 2011ZX09304-07V1.2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Unstable Angina Pectoris

Keywords

Unstable Angina Pectoris; Randomized Controlled Trial; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total score of symptoms questionnaire of TCM

  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)

  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

  Day 0, Day 28

Study Arms (2)

Danhong injection

EXPERIMENTAL

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; Other: Standard medical care

Placebo

PLACEBO COMPARATOR

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.

Other: Standard medical care; Drug: Placebo

Interventions

Danhong injection DRUG

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

Danhong injection

Standard medical care OTHER

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

Danhong injection; Placebo

Placebo 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.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• China Food and Drug Administration: collaborator

Study Sites (9)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

Location

The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

Zhengzhou No.7 People's Hospital

Zhengzhou, Henan, 450006, China

Location

The First Hospital of Changsha

Changsha, Hunan, 410005, China

Location

The Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, Jilin, 130021, China

Location

Hospital 463 of P.L.A.

Shenyang, Liaoning, 110046, China

Location

First Teaching Hospital of Tianjin University of T.C.M.

Tianjin, Tianjin Municipality, 300193, China

Location

Related Publications (1)

• 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.

  PMID: 34732357 DERIVED

MeSH Terms

Conditions

Angina, Unstable

Interventions

danhong

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Xiao-xi Du, Professor

  China Food and Drug Administration

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

CN (9)