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

August 17, 2016 updated by: Zhu Mingjun
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 curative effect and security.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • First affiliated hospital, Henan University of Traditional Chinese medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
  2. Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
  3. Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
  4. Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
  5. Active tuberculosis or rheumatoid diseases;
  6. Nosohemia, organ transplantation,uremia;
  7. Psychosis and drug abuse;
  8. Allergic to the drugs or one component medicine of the drugs of this study ;
  9. Participated in other trials within 1 month ;
  10. Being pregnant, planning for pregnancy or breastfeeding;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tonifying qi group
tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
Drug: Yiqi prescription
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Experimental: activating blood group
which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Huoxue prescription
Experimental: qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Buyang huanwu decoction
Active Comparator: QISHEN YIQI DRIPPING PILLS group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
Drug: QISHEN YIQI DRIPPING PILLS
Drug: Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
Sham Comparator: placebo group
which treated by the simulation of Chinese patent medicine (major components:excipient)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 0 month
0 month
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 3rd month
3rd month
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 9th month
9th month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minnesota heart failure quality of life scale
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP
Time Frame: 0，3rd month
the expression of these may be related to "Qi"
0，3rd month
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
Time Frame: 0，3rd month
the expression of these may be related to "Xue"
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
the expression of these may be related to "Mai"
0，3rd month
Echocardiography
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
Cardiac magnetic resonance
Time Frame: 0，3rd month
baseline, 3 months after treatment
0，3rd month
Vascular ultrasound
Time Frame: 0，3rd month
baseline, and after 3 months treatment
0，3rd month
Endothelial function
Time Frame: 0，3rd month
baseline, and after 3 months treatment
0，3rd month
Cardiac function classification, NYHA
Time Frame: 0,1st,Sec,3rd,6th,9th,month
baseline, 3 months after treatment and follow-up 6 months
0,1st,Sec,3rd,6th,9th,month
ultrasonic cardiogram
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
6MWT distance
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
blood and urine routine tests,liver and renal function tests,serum
Time Frame: 0,3rd,month
safety evaluation
0,3rd,month
electrolytes,electrocardiogram (ECG)
Time Frame: 0,3rd,month
safety evaluation
0,3rd,month
Composite endpoint
Time Frame: 1st,3rd,6th,9th, month
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.
1st,3rd,6th,9th, month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhu Mingjun

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zhu M jun, First affiliated hospital, Henan University of Traditional Chinese medicine
  • Principal Investigator: Wang Y xia, First affiliated hospital, Henan University of Traditional Chinese medicine
  • Principal Investigator: Li Bin, First affiliated hospital, Henan University of Traditional Chinese medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015CB554401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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