UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026621
Receipt No. 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 (Ver. 7)

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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
Email 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
Email hirotakaezaki@gmail.com

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030576