NCT02875639

Brief 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 curative effect and security.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

August 2, 2016

Last Update Submit

August 17, 2016

Conditions

Ischemic Heart Failure

Keywords

Ischemic Heart Failurecoronary artery diseaseqi deficiency and blood stasis

Outcome Measures

Primary Outcomes (3)

  • N-terminal pronatriuretic peptide（NT-proBNP）

    0 month

  • N-terminal pronatriuretic peptide（NT-proBNP）

    3rd month

  • N-terminal pronatriuretic peptide（NT-proBNP）

    9th month

Secondary Outcomes (15)

  • Minnesota heart failure quality of life scale

    0,3rd,9th month

  • sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP

    0，3rd month

  • TXA2,PGI2,CD31,CD18,CD11b,R,K,MA

    0，3rd month

  • hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1

    0，3rd month

  • Echocardiography

    0,3rd,9th month

  • +10 more secondary outcomes

Study Arms (5)

tonifying qi group

EXPERIMENTAL

tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)

Drug: Yiqi prescriptionDrug: Placebo 1

activating blood group

EXPERIMENTAL

which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)

Drug: Huoxue prescriptionDrug: 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)

Drug: Buyang huanwu decoctionDrug: 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)

Drug: QISHEN YIQI DRIPPING PILLSDrug: Placebo 2

placebo group

SHAM COMPARATOR

which treated by the simulation of Chinese patent medicine (major components:excipient)

Drug: Placebo 1Drug: Placebo 2

Interventions

Yiqi prescriptionDRUG
tonifying qi group
Huoxue prescriptionDRUG
activating blood group
Buyang huanwu decoctionDRUG
qi and blood group
QISHEN YIQI DRIPPING PILLSDRUG
QISHEN YIQI DRIPPING PILLS group
Placebo 1DRUG

Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.

activating blood groupplacebo groupqi and blood grouptonifying qi group
Placebo 2DRUG

Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

QISHEN YIQI DRIPPING PILLS groupplacebo group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital, Henan University of Traditional Chinese medicine

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23741058RESULT

  • 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.

    PMID: 39175547DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

buyang huanwu

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Zhu M jun

    First affiliated hospital, Henan University of Traditional Chinese medicine

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Y xia

CONTACT

13838571596wyxchzhq@163.com

Li Bin

CONTACT

13633811795libinnvhai@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor,chief physicians,the director of Henan University of Traditional Chinese Medicine

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 23, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)