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Unstable Angina PectorisPhase 4NCT02007187

Danhong Injection in the Treatment of Unstable Angina Pectoris

A Phase 4 study testing Danhong injection and Standard medical care in people with Unstable Angina Pectoris, run by China Academy of Chinese Medical Sciences at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Unstable Angina Pectoris
What is being tested?
Danhong injection and Standard medical care
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
9 sitesChina
Study dates
Dec 2013to Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Xuanwu Hospital

    Beijing, Beijing Municipality, 100053

  • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100700

  • The Affiliated Hospital to Changchun University of Chinese Medicine

    Changchun, Jilin, 130021

  • The First Hospital of Changsha

    Changsha, Hunan, 410005

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510405

  • The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

    Harbin, Heilongjiang, 150040

  • Hospital 463 of P.L.A.

    Shenyang, Liaoning, 110046

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

    Tianjin, Tianjin Municipality, 300193

  • Zhengzhou No.7 People's Hospital

    Zhengzhou, Henan, 450006

Other trials in China

About this study

Official title: 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.

Being tested
Danhong injection, Standard medical care, Placebo
Keywords
Unstable Angina Pectoris, Randomized Controlled Trial, Traditional Chinese Medicine
Medical subject headings
Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Danhong injectionDrug

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

  • Standard medical careOther

    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

  • PlaceboDrug

    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.

Study groups in NCT02007187
Study groupRoleWhat they receive
Danhong injectionExperimentalBased 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.
Receives: Drug: Danhong injection; Other: Standard medical care
PlaceboPlacebo comparatorBased 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.
Receives: Other: Standard medical care; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 7

Secondary outcomes (6)

  1. 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.

    Measured: Day 0, Day 7

  2. Use of Short-acting Nitrates

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

  3. 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.

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

  4. The proportion of patients who are undergoing PCI

    Measured: Day 7, Day 28

  5. 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.

    Measured: Day 0, Day 28

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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007187
Sponsor's protocol ID
2011ZX09304-07V1.2
Status last verified
Nov 2017
First submitted
5 Dec 2013
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 34732357

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Danhong injection and Standard medical care in people with Unstable Angina Pectoris, run by China Academy of Chinese Medical Sciences at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of the Quantification score of angina pectoris at Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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