Ischemic Heart FailurePhase 2NCT02875639

A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)

A Phase 2 study testing Yiqi prescription, Huoxue prescription and Buyang huanwu decoction in people with Ischemic Heart Failure, run by Zhu Mingjun at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis. And at the same time this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of coronary heart disease (CHD) heart failure the… Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Ischemic Heart Failure
What is being tested?: Yiqi prescription, Huoxue prescription and Buyang huanwu decoction
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteChina
Study dates: Jun 2016to Dec 2019
Phase: Phase 2
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 40 to 75;
Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
Qi deficiency and blood stasis syndrome;
New York Heart Association (NYHA) Class II to Ⅲ ;
Submitted informed consent

Who cannot join

Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
Active tuberculosis or rheumatoid diseases;
Nosohemia, organ transplantation,uremia;

Show all 10Show fewer

Psychosis and drug abuse;
Allergic to the drugs or one component medicine of the drugs of this study ;
Participated in other trials within 1 month ;
Being pregnant, planning for pregnancy or breastfeeding;

Trial locations and contacts

1 site in 1 country.

Wang Y xia contact

Li Bin contact

China1 site, 1 recruiting

First affiliated hospital, Henan University of Traditional Chinese medicine
Zhengzhou, Henan, 450000
Wang Y xia, 13838571596, wyxchzhq@163.com
Li Bin, 13633811795, libinnvhai@163.com
Recruiting

Other trials in China

About this study

Read the detailed description

Modern research has shown that the main mechanism of the qi deficiency and blood stasis of coronary disease combined with cardiac failure is the disorder Nerve-endocrine-immune network mechanism, disorder of energy metabolism, blood coagulation/anticoagulation imbalances, vascular endothelial injury and the expression of inflammatory factors and cytokines disorder, etc. Some studies have identified that the Chinese traditional medicine of supplementing qi and activating blood circulation drugs could adjust the nerve - endocrine - immune network, improve endothelial function, improve ventricular remodeling, ameliorate heart function, alleviate the clinical symptoms, enhance the quality of life, and so on. This study by comparing the curative effect of Yi-Qi Formula, Huoxue prescription and two prescription of yiqi huoxue (buyang huanwu decoction and Qishen Yiqi Drop Pill) on improving energy metabolism, ameliorating heart function, adjusting the blood coagulation and the expression of cell adhesion factor, improving endothelial function, to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis, and confirm the TCM theory that "Qi and blood are correlated.

Conditions: Ischemic Heart Failure
Being tested: Yiqi prescription, Huoxue prescription, Buyang huanwu decoction, QISHEN YIQI DRIPPING PILLS, Placebo 1
Keywords: Ischemic Heart Failure, coronary artery disease, qi deficiency and blood stasis
Medical subject headings: Coronary Artery Disease

What participants receive

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

Yiqi prescriptionDrug
Huoxue prescriptionDrug
Buyang huanwu decoctionDrug
QISHEN YIQI DRIPPING PILLSDrug
Placebo 1Drug
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Placebo 2Drug
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

Study groups in NCT02875639
Study group	Role	What they receive
tonifying qi group	Experimental	tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on) Receives: Drug: Yiqi prescription; Drug: Placebo 1
activating blood group	Experimental	which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on) Receives: Drug: Huoxue prescription; Drug: Placebo 1
qi and blood group	Experimental	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on) Receives: Drug: Buyang huanwu decoction; Drug: Placebo 1
QISHEN YIQI DRIPPING PILLS group	Active comparator	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on) Receives: Drug: QISHEN YIQI DRIPPING PILLS; Drug: Placebo 2
placebo group	Sham comparator	which treated by the simulation of Chinese patent medicine (major components:excipient) Receives: Drug: Placebo 1; Drug: Placebo 2

What is being measured

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

N-terminal pronatriuretic peptide（NT-proBNP）
Measured: 0 month
N-terminal pronatriuretic peptide（NT-proBNP）
Measured: 3rd month
N-terminal pronatriuretic peptide（NT-proBNP）
Measured: 9th month

Secondary outcomes (15)

Minnesota heart failure quality of life scale
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,3rd,9th month
sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP
the expression of these may be related to "Qi"
Measured: 0，3rd month
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
the expression of these may be related to "Xue"
Measured: 0，3rd month
hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1
the expression of these may be related to "Mai"
Measured: 0，3rd month
Echocardiography
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,3rd,9th month
Cardiac magnetic resonance
baseline, 3 months after treatment
Measured: 0，3rd month
Vascular ultrasound
baseline, and after 3 months treatment
Measured: 0，3rd month
Endothelial function
baseline, and after 3 months treatment
Measured: 0，3rd month
Cardiac function classification, NYHA
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,1st,Sec,3rd,6th,9th,month
ultrasonic cardiogram
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,3rd,9th month
6MWT distance
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,3rd,9th month
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
baseline, 3 months after treatment and follow-up 6 months
Measured: 0,3rd,9th month
blood and urine routine tests,liver and renal function tests,serum
safety evaluation
Measured: 0,3rd,month
electrolytes,electrocardiogram (ECG)
safety evaluation
Measured: 0,3rd,month
Composite endpoint
all-cause death, frequency of emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.
Measured: 1st,3rd,6th,9th, month

Timeline

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

Jun 2016Dec 2019

First posted23 Aug 2016 (estimated)
Study startJun 2016
Primary completionDec 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 (2)Papers the sponsor has linked to this study.
Other trials for Ischemic Heart FailureStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02875639
Sponsor's protocol ID: 2015CB554401
Status last verified: Aug 2016
First submitted: 2 Aug 2016
Last updated: 23 Aug 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
PubMed 23741058
Zhao Z, Jin X, Li Y, Wang X, Cui Y, Zhang B, Kang Y, Zhang G, Chu Q, Zhang J. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients: protocol for a prospective, single-center, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2024 Aug 8;15:1378081. doi: 10.3389/fphar.2024.1378081. eCollection 2024.
PubMed 39175547

Want to know more?

Wang Y xia

13838571596

wyxchzhq@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute

All Ischemic Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)
ClinicalTrials.gov ID: NCT02875639
Acronym / sponsor ID: 2015CB554401
Conditions: Ischemic Heart Failure
Keywords: Ischemic Heart Failure, coronary artery disease, qi deficiency and blood stasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 180 participants (estimated)
Lead sponsor: Zhu MingjunUniversity, hospital or other
Study start: Jun 2016
Primary completion: Dec 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 23 Aug 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 5

Arm	Type	Receives
tonifying qi group	Experimental	Drug: Yiqi prescription, Drug: Placebo 1tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
activating blood group	Experimental	Drug: Huoxue prescription, Drug: Placebo 1which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
qi and blood group	Experimental	Drug: Buyang huanwu decoction, Drug: Placebo 1which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
QISHEN YIQI DRIPPING PILLS group	Active comparator	Drug: QISHEN YIQI DRIPPING PILLS, Drug: Placebo 2which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
placebo group	Sham comparator	Drug: Placebo 1, Drug: Placebo 2which treated by the simulation of Chinese patent medicine (major components:excipient)

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 40 to 75;
Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
Qi deficiency and blood stasis syndrome;
New York Heart Association (NYHA) Class II to Ⅲ ;
Submitted informed consent

Key exclusion criteria (10 listed)

Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
Active tuberculosis or rheumatoid diseases;

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
Yiqi prescription	Drug	tonifying qi group
Huoxue prescription	Drug	activating blood group
Buyang huanwu decoction	Drug	qi and blood group
QISHEN YIQI DRIPPING PILLS	Drug	QISHEN YIQI DRIPPING PILLS group
Placebo 1Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.	Drug	activating blood group, placebo group, qi and blood group, tonifying qi group
Placebo 2Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.	Drug	QISHEN YIQI DRIPPING PILLS group, placebo group

Primary outcome

N-terminal pronatriuretic peptide（NT-proBNP）
Time frame: 0 month
N-terminal pronatriuretic peptide（NT-proBNP）
Time frame: 3rd month
N-terminal pronatriuretic peptide（NT-proBNP）
Time frame: 9th month

15 secondary outcomes

Minnesota heart failure quality of life scale
Time frame: 0,3rd,9th month
sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP
Time frame: 0，3rd month
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
Time frame: 0，3rd month
hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1
Time frame: 0，3rd month
Echocardiography
Time frame: 0,3rd,9th month
Cardiac magnetic resonance
Time frame: 0，3rd month
Vascular ultrasound
Time frame: 0，3rd month
Endothelial function
Time frame: 0，3rd month
Cardiac function classification, NYHA
Time frame: 0,1st,Sec,3rd,6th,9th,month
ultrasonic cardiogram
Time frame: 0,3rd,9th month
6MWT distance
Time frame: 0,3rd,9th month
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Time frame: 0,3rd,9th month
blood and urine routine tests,liver and renal function tests,serum
Time frame: 0,3rd,month
electrolytes,electrocardiogram (ECG)
Time frame: 0,3rd,month
Composite endpoint
Time frame: 1st,3rd,6th,9th, month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
Results publication: PubMed 23741058WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
Derived from this study: PubMed 39175547Zhao Z, Jin X, Li Y, Wang X, Cui Y, Zhang B, Kang Y, Zhang G, Chu Q, Zhang J. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients: protocol for a prospective, single-center, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2024 Aug 8;15:1378081. doi: 10.3389/fphar.2024.1378081. eCollection 2024.
Individual participant dataSharing planned: No

Related trials for Ischemic Heart Failure

Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute

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.

Wang Y xia contact

Li Bin contact

Zhu M jun study director

First affiliated hospital, Henan University of Traditional Chinese medicine

Wang Y xia principal investigator

First affiliated hospital, Henan University of Traditional Chinese medicine

Li Bin principal investigator

First affiliated hospital, Henan University of Traditional Chinese medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Yiqi prescription, Huoxue prescription and Buyang huanwu decoction in people with Ischemic Heart Failure, run by Zhu Mingjun at 1 site 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 10 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Wang Y xia (13838571596, wyxchzhq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N-terminal pronatriuretic peptide（NT-proBNP） (time frame: 0 month). The study lists 3 primary outcomes in all. 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 NCT02875639, which also lists 2 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 23 Aug 2016.