UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026621 |
|---|---|
| Receipt number | R000030576 |
| Scientific Title | Study of the efficacy of Mokuboito in patients with acute decompensated heart failure. |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2019/09/23 12:39:53 |
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Basic information
Public title
Study of the efficacy of Mokuboito in patients with acute decompensated heart failure.
Acronym
The efficacy of Mokuboito in patients with ADHF.
Scientific Title
Study of the efficacy of Mokuboito in patients with acute decompensated heart failure.
Scientific Title:Acronym
The efficacy of Mokuboito in patients with ADHF.
Region
| Japan |
Condition
Condition
Acute decompensated heart failure(ADHF)
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of Mokuboito in patients with ADHF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in global clinical status based on a visual analog scale and body weight at day 10 or discharge if earlier.
Key secondary outcomes
The change of plasma brain natriuretic peptide concentration, parameters measured using echocardiography, and the degree of peripheral edema at day 10 or discharge if earlier.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Additional administration of Mokuboito 7.5g/day on standard therapy for ADHF.
Interventions/Control_2
Standard therapy for ADHF
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who need admission due to ADHF
2) Patients who gave written informed consent
Key exclusion criteria
1) Patients younger than 20 years old
2) Patients who cannot make oral communication due to shock state or intubation
3) Patients who are pregnant or hope to be pregnant
4) Patients who cannot take oral administration
5) Patients who have allergy for cinnamon
6) Patients who cannot undergo proper medical examination or body weight measurement due to orthopnea
7) Patients whose doctor in charge do not agree to join the trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Sakurada |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
3591142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
hirotakaezaki@gmail.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
3591142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
Homepage URL
hirotakaezaki@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Tokorozawa Heart Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee in Tokorozawa Heart Center
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel
04-2940-8611
cs.thc@oukai.or.jp
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
所沢ハートセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
http://shintoko.org/wordpress/wp-content/uploads/2017/03/%E6%9C%A8%E9%98%B2%E5%B7%B2%E6%B9%AF%E8%A8%
Publication of results
Published
Result
URL related to results and publications
https://www.journal-of-cardiology.com/article/S0914-5087(19)30141-8/fulltext
Number of participants that the trial has enrolled
40
Results
Oral administration of Mokuboito significantly improved ADHF-related symptoms. Our observations might provide the basis for a novel therapeutic strategy in hospitalized patients with ADHF.
Results date posted
| 2019 | Year | 09 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hospitalized patients with acute decompensated heart filure.
Participant flow
Forty patients were allocated randomly to Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy). The primary outcome was changes in global clinical status based on a visual analog scale (VAS) from baseline at day 10 or discharge if earlier.
Adverse events
none
Outcome measures
The primary endpoint was patient-assessed changes in global clinical status based on a visual analog scale (VAS, described in detail below) at day 0 (on admission) and day 10 or discharge if earlier. Secondary endpoints were changes in body weight, plasma brain natriuretic peptide (BNP) concentration, echocardiographic and biochemical parameters, and the degree of peripheral edema, at day 0 and day 10 or discharge if earlier.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030576
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