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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032889
Receipt No. R000037502
Official scientific title of the study 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

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Basic information
Official scientific title of the study Study of the clinical outcome of Goreisan in patients with abnormal fluid retention.
Title of the study (Brief title) 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 Masami Sakurada
Organization Tokorozawa Heart Center
Division name Department of Cardiology
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL 04-2940-8611
Email hirotakaezaki@gmail.com

Public contact
Name of contact person Hirotaka Ezaki
Organization Tokorozawa Heart Center
Division name Department of Cardiology
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037502

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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