UMIN-CTR Clinical Trial

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