UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012762 |
|---|---|
| Receipt number | 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 08:46:07 |
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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
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
izawa611@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014684
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
