A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)
NCT ID: NCT02875639
Last Updated: 2016-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2016-06-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tonifying qi group
tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
Yiqi prescription
Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
activating blood group
which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
Huoxue prescription
Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
Buyang huanwu decoction
Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
QISHEN YIQI DRIPPING PILLS group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
QISHEN YIQI DRIPPING PILLS
Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
placebo group
which treated by the simulation of Chinese patent medicine (major components:excipient)
Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
Interventions
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Yiqi prescription
Huoxue prescription
Buyang huanwu decoction
QISHEN YIQI DRIPPING PILLS
Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
Eligibility Criteria
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Inclusion Criteria
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
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;
40 Years
75 Years
ALL
No
Sponsors
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Zhu Mingjun
OTHER
Responsible Party
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Zhu Mingjun
Professor,chief physicians,the director of Henan University of Traditional Chinese Medicine
Principal Investigators
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Zhu M jun
Role: STUDY_DIRECTOR
First affiliated hospital, Henan University of Traditional Chinese medicine
Wang Y xia
Role: PRINCIPAL_INVESTIGATOR
First affiliated hospital, Henan University of Traditional Chinese medicine
Li Bin
Role: PRINCIPAL_INVESTIGATOR
First affiliated hospital, Henan University of Traditional Chinese medicine
Locations
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First affiliated hospital, Henan University of Traditional Chinese medicine
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2015CB554401
Identifier Type: -
Identifier Source: org_study_id
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