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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012762
Receipt No. R000014684
Scientific Title Assessment of traditional Japanese Kampo effects in patients with chronic heart failure
Date of disclosure of the study information 2014/01/06
Last modified on 2016/12/20

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Basic information
Public title Assessment of traditional Japanese Kampo effects in patients with chronic heart failure
Acronym Japanese Kampo medicine in chronic heart failure
Scientific Title Assessment of traditional Japanese Kampo effects in patients with chronic heart failure
Scientific Title:Acronym Japanese Kampo medicine in chronic heart failure
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of efficacy and safety of Japanese Kampo medicine in patients with chronic heart failure
Basic objectives2 Others
Basic objectives -Others This study was designed to evaluate status of heart failure and renal function after treatment with Kampo medicine in chronic heart failure patients with cardiorenal syndrome.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Status of heart failure (NYHA classification, level of brain natriuretic peptide)
Renal function (levels of serum creatinine, estimated glomerular filtration ratio)
Key secondary outcomes Adverse effects

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Chronic heart failure patients with cardiorenal syndrome:
1) Stable compensated patients with chronic heart failure classified as New York Heart Association (NYHA) functional class I-III.
2) Chronic heart failure Stage B or Stage C
3) Estimated glomerular filtration rate, eGFR < 65 mL/min/1.73 m2
Key exclusion criteria Patients with:
1) intravascular volume depletion
2) indications for hemodialysis or acute kidney injury
3) sepsis or ongoing infection
4) alcohol and/or drug abuse
5) hepatic insufficiency
6) known allergy to the study medication or any of its components
7) enrollment in other clinical trials involving medical or device based interventions
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uichi Ikeda
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto 390-8621, Nagano, Japan
TEL 0263-37-3352
Email uikeda@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Izawa
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto 390-8621, Nagano, Japan
TEL 0263-37-3352
Homepage URL
Email izawa611@shinshu-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical endpoints were analysed at 3 points as follows: 1) before initiation of the treatment, and followed at mean intervals of 2) 3.5 and 3) 9.4 months after starting the treatment.

Management information
Registered date
2014 Year 01 Month 06 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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