Unstable AnginaPhase 4NCT03179514
Effect of Gualou Xiebai Banxia Decoction With Danshen Decoction in Treating Unstable Angina.
A Phase 4 study testing Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator in people with Unstable Angina, run by Jun Li.
Trial summary
This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be divided into 2 arms randomly. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Unstable Angina
- What is being tested?
- Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;
- Patients have at least one of these symptoms:
- The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
- Angina pectoris during rest;
- The recent occurrence of angina pectoris caused by mild physical activity in the last month.
Who cannot join
- Patients diagnosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on the Clinical Effect of Gualou Xiebai Banxia Decoction Compounded With Danshen Decoction in Treating Unstable Angina.
This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, the other one will be treated by Gualou Xiebai Banxia Decoction compounded with Danshen Decoction at the base of conventional western medicine.
Read the detailed description
Gualou Xiebai Banxia Decoction compounded with Danshen Decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type.
- Conditions
- Unstable Angina
- Being tested
- Anti-Platelet Drugs, Lipid Regulating Drugs, Coronary Vasodilator, Gualou Xiebai Banxia Decoction & Danshen Decoction
- Keywords
- Unstable Angina, Gualou Xiebai Banxia Decoction, Danshen Decoction
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Platelet DrugsDrug
Including aspirin and clopidogrel, etc.
Lipid Regulating DrugsDrug
Mainly including statins
Coronary VasodilatorDrug
Mainly including nitrates
Gualou Xiebai Banxia Decoction & Danshen DecoctionDrug
Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.
| Study group | Role | What they receive |
|---|---|---|
| Phlegm and blood stasis | Experimental | Patients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine. Receives: Drug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator; Drug: Gualou Xiebai Banxia Decoction & Danshen Decoction |
| Conventional western medicine | Other | Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc. Receives: Drug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death caused by cardiovascular disease
Measured: Six months after drug intervention
Secondary outcomes (4)
Myocardial enzymes
The unit is mmol/L
Measured: At baseline and 4 weeks after drug intervention
lood lipid The unit is mmol/L. Blood lipid
The unit is mmol/L.
Measured: At baseline and 4 weeks after drug intervention
Treadmill exercise test
The result will be positive or negative.
Measured: At baseline and 4 weeks after drug intervention
The incidence of myocardial infarction or heart failure
Measured: Six months after drug intervention] Inclusion Criteria:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unstable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Li
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor-investigator, Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jun Li, MD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179514
- Sponsor's protocol ID
- GLXB-2017
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang J, Yu G. A Systems Biology Approach to Characterize Biomarkers for Blood Stasis Syndrome of Unstable Angina Patients by Integrating MicroRNA and Messenger RNA Expression Profiling. Evid Based Complement Alternat Med. 2013;2013:510208. doi: 10.1155/2013/510208. Epub 2013 May 14.
PubMed 23762142Qiu Y, Xu H, Shi D. Traditional chinese herbal products for coronary heart disease: an overview of cochrane reviews. Evid Based Complement Alternat Med. 2012;2012:417387. doi: 10.1155/2012/417387. Epub 2012 Mar 28.
PubMed 22536282Liu W, Xiong X, Yang X, Chu F, Liu H. The Effect of Chinese Herbal Medicine Gualouxiebaibanxia Decoction for the Treatment of Angina Pectoris: A Systematic Review. Evid Based Complement Alternat Med. 2016;2016:8565907. doi: 10.1155/2016/8565907. Epub 2016 Sep 29.
PubMed 27777598Wang J, Yang X, Chu F, Chen J, He Q, Yao K, Teng F, Gao Y, Xing Y, Wu A, Xing Y. The effects of xuefu zhuyu and shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:896467. doi: 10.1155/2013/896467. Epub 2013 May 8.
PubMed 23737852
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Clinical Effect of Gualou Xiebai Banxia Decoction Compounded With Danshen Decoction in Treating Unstable Angina.
- ClinicalTrials.gov ID
- NCT03179514
- Acronym / sponsor ID
- GLXB-2017
- Conditions
- Unstable Angina
- Keywords
- Unstable Angina, Gualou Xiebai Banxia Decoction, Danshen Decoction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jun LiUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- Jul 2017 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, the other one will be treated by Gualou Xiebai Banxia Decoction compounded with Danshen Decoction at the base of conventional western medicine.
Detailed description
Gualou Xiebai Banxia Decoction compounded with Danshen Decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phlegm and blood stasis | Experimental | Drug: Anti-Platelet Drugs, Drug: Lipid Regulating Drugs, Drug: Coronary Vasodilator, Drug: Gualou Xiebai Banxia Decoction & Danshen DecoctionPatients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine. |
| Conventional western medicine | Other | Drug: Anti-Platelet Drugs, Drug: Lipid Regulating Drugs, Drug: Coronary VasodilatorPatients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;
- The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
- Angina pectoris during rest;
- The recent occurrence of angina pectoris caused by mild physical activity in the last month.
Key exclusion criteria (1 listed)
- Patients diagnosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Platelet DrugsIncluding aspirin and clopidogrel, etc. | Drug | Conventional western medicine, Phlegm and blood stasis |
| Lipid Regulating DrugsMainly including statins | Drug | Conventional western medicine, Phlegm and blood stasis |
| Coronary VasodilatorMainly including nitrates | Drug | Conventional western medicine, Phlegm and blood stasis |
| Gualou Xiebai Banxia Decoction & Danshen DecoctionMainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc. | Drug | Phlegm and blood stasis |
Primary outcome
Mortality
Time frame: Six months after drug intervention
Death caused by cardiovascular disease
4 secondary outcomes
Myocardial enzymes
Time frame: At baseline and 4 weeks after drug intervention
lood lipid The unit is mmol/L. Blood lipid
Time frame: At baseline and 4 weeks after drug intervention
Treadmill exercise test
Time frame: At baseline and 4 weeks after drug intervention
The incidence of myocardial infarction or heart failure
Time frame: Six months after drug intervention] Inclusion Criteria:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Results publication: PubMed 23762142Wang J, Yu G. A Systems Biology Approach to Characterize Biomarkers for Blood Stasis Syndrome of Unstable Angina Patients by Integrating MicroRNA and Messenger RNA Expression Profiling. Evid Based Complement Alternat Med. 2013;2013:510208. doi: 10.1155/2013/510208. Epub 2013 May 14.
- Results publication: PubMed 22536282Qiu Y, Xu H, Shi D. Traditional chinese herbal products for coronary heart disease: an overview of cochrane reviews. Evid Based Complement Alternat Med. 2012;2012:417387. doi: 10.1155/2012/417387. Epub 2012 Mar 28.
- Results publication: PubMed 27777598Liu W, Xiong X, Yang X, Chu F, Liu H. The Effect of Chinese Herbal Medicine Gualouxiebaibanxia Decoction for the Treatment of Angina Pectoris: A Systematic Review. Evid Based Complement Alternat Med. 2016;2016:8565907. doi: 10.1155/2016/8565907. Epub 2016 Sep 29.
- Results publication: PubMed 23737852Wang J, Yang X, Chu F, Chen J, He Q, Yao K, Teng F, Gao Y, Xing Y, Wu A, Xing Y. The effects of xuefu zhuyu and shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:896467. doi: 10.1155/2013/896467. Epub 2013 May 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Li, MD study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator in people with Unstable Angina, run by Jun Li.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panpan Tian (+86 15652388175, 15652388175@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Six months after drug intervention). 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 NCT03179514, which also lists 4 linked publications.
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 7 Jun 2017.