UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032889 |
|---|---|
| Receipt number | R000037502 |
| Scientific Title | Study of the clinical outcome of Goreisan in patients with abnormal fluid retention. |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2018/10/10 13:28:28 |
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Basic information
Public title
Study of the clinical outcome of Goreisan in patients with abnormal fluid retention.
Acronym
Study of the clinical outcome of Goreisan in patients with abnormal fluid retention.
Scientific Title
Study of the clinical outcome of Goreisan in patients with abnormal fluid retention.
Scientific Title:Acronym
Study of the clinical outcome of Goreisan in patients with abnormal fluid retention.
Region
| Japan |
Condition
Condition
Abnormal fluid retention
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of Goreisan in patients with abnormal fluid retention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A total of 3days urine volume form the day after participation in this study.
Key secondary outcomes
Serum creatinine, electrolyte, liver enzyme, body weight, and the degree of peripheral edema.
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 Goreisan 7.5g/day on intravenous injection of diuretics for abnormal fluid retention.
Interventions/Control_2
Intravenous injection of diuretics for abnormal fluid retention.
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 intravenous injection of diuretics due to abnormal fluid retention.
2) Patients who gave written informed consent
Key exclusion criteria
1) Patients younger than 20 years old
2) Patients who have allergy for cinnamon
3) Patients who are pregnant or hope to be pregnant
4) Patients who cannot take oral administration
5) Patients who have no urination due to end-stage renal failure on hemodialysis
6) Patients who are not expected to react to diuretics due to acute kidney injury
7) Patients who participate in another interventional trial
8) 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 | |
| Middle name | |
| Last name | Masami Sakurada |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
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 | |
| Middle name | |
| Last name | Hirotaka Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
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
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
所沢ハートセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 06 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037502
