UMIN-CTR Clinical Trial

Basic information
Public title	Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Acronym	Is Goreisan effective for preventing postoperative nausea and vomiting?
Scientific Title	Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Scientific Title:Acronym	Is Goreisan effective for preventing postoperative nausea and vomiting?
Region	Japan

Condition
Condition	Postoperative Nausea and Vomiting
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of Goreisan for postoperative nausea and vomiting with gynecological patients after general anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The severity of postoperative nausea and vomiting evaluated by objective scaling number. The total amount of antiemetic drug dosage used for postoperative nausea and vomiting.
Key secondary outcomes	The severity of postoperative pain evaluated by objective scaling number. The amount of analgesic drug dosage needed to control patients pain.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Food
Interventions/Control_1	Before the surgical operation is completed, we administer Goreisan through a gastric tube.
Interventions/Control_2	Before the surgical operation is completed, we administer normal saline through a gastric tube.
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	50 years-old >=
Gender	Female
Key inclusion criteria	Gynecological elective surgery patients with general anesthesia
Key exclusion criteria	Severe preoperative complications Severe postoperative complications History of the Chinese herb usage History of the chemotherapy for malignnant deseases
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Ozaki
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Zip code
Address	Tokyo, Japan 162-8666
TEL	03-3353-8111
Email	mozaki@anes.twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keiko Kume
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Zip code
Address	Tokyo, Japan 162-8666
TEL	03-3353-8111
Homepage URL
Email	kkume@anes.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
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
Email

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	東京女子医科大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

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	Completed
Date of protocol fixation	2013 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2018 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date	2013 Year 09 Month 18 Day
Last modified on	2018 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013731

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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