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Completed

NCT Number: NCT02007187

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danhong injection

Drug

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

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

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.

Primary outcomes

  1. Change from baseline of the Quantification score of angina pectoris at Day 7

    Time frame: 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 outcomes

  1. Total score of symptoms questionnaire of TCM

    Time frame: Day 0, Day 7

    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.

  2. 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

  3. Change in the electrocardiogram (ECG)

    Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28

    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.

  4. The proportion of patients who are undergoing PCI

    Time frame: Day 7, Day 28

  5. Change in Seattle Angina Questionnaire

    Time frame: Day 0, Day 28

    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.

  6. Incidence of adverse events (including serious adverse events) in 28 days

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

  • China Food and Drug Administration

Registry information

Official study title

A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2013
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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