UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018381
Receipt number R000021283
Scientific Title The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Date of disclosure of the study information 2015/08/01
Last modified on 2017/04/16 22:01:06

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Basic information

Public title

The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients

Acronym

The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients

Scientific Title

The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients

Scientific Title:Acronym

The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients

Region

Japan


Condition

Condition

women who will receive laparoscopic gynecologic surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Syouhangekabukuryouto 3g

Interventions/Control_2

lactose 3g

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

60 years-old >=

Gender

Female

Key inclusion criteria

patients over 20 years oldwho will receive laparoscopic gynecologic surgery under general anesthesia at our institution

Key exclusion criteria

Patients who will receive an emergency operation
Patients who have allergic reaction to drugs
Patients who used prophylactic antiemetic drugs whithin 24 hours before operation
Patients who used analgetic drugs whithin 24 hours before operation
Patients who have used Chinese harb
Patients who is lactose intolerant
Patients who we couldn't get a consent form

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makito Kanako

Organization

Saiseikai central hospital

Division name

Department of Anesthesiology

Zip code


Address

1-4-17 mita minato-ku Tokyo Japan

TEL

03-3451-8211

Email

canakana87@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name makito kanako

Organization

Saiseikai Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-4-17 mita minato-ku Tokyo Japan

TEL

03-3451-8211

Homepage URL


Email

canakana87@gmail.com


Sponsor or person

Institute

Saiseikai Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Saiseikai Central Hospital Anesthesiology

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



Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 01 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

Completed

Date of protocol fixation

2015 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 15 Day

Last follow-up date

2016 Year 11 Month 03 Day

Date of closure to data entry


Date trial data considered complete

2016 Year 11 Month 03 Day

Date analysis concluded

2016 Year 11 Month 03 Day


Other

Other related information



Management information

Registered date

2015 Year 07 Month 22 Day

Last modified on

2017 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name