UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the Goreisan prophylaxis on headache after the cesarean operation
Title of the study (Brief title)	Goreisan prophylaxis
Region	Japan

Condition
Condition	headache
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For postdural puncture headache (PDPH) by the spinal anesthesia after the cesarean operation, case report and the case series which were improved by giving Goreisan are reported until now. However, it is unknown how much prophylaxis of the Goreisan is effective against.Therefore, I examined it this time.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	headache from the operation end to a discharge
Key secondary outcomes	nuesa/vomitting, breast feeding and milking, days from the operation end to a discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	The Goreisan administrated group From drinking water possible time of cesarean operation, administered Goreisan content of 3 3 days
Interventions/Control_2	Goreisan non-administrated group
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	The pregnant woman of ASA PS 1, 1E, 2, 2E were planned by epidural combination spinal anesthesia.
Key exclusion criteria	Patient having a migraine headache an allergy to cinnamon bark or the lactose intolerance symptom The patient with mental disease or a mind symptom is judged to have difficulty in trial entry. The patient who is given NSAIDS, acetaminophen before operation
Target sample size	200

Research contact person
Name of lead principal investigator	Masanori Yamauchi
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
Address	seiryo-cho 1-1 aoba-ku sendai-si miyagi-ken
TEL	022-717-7321
Email	yamauchi@med.tohoku.ac.jp

Public contact
Name of contact person	Hiroshi Sumida
Organization	Tohoku University
Division name	Department of Anesthesiology
Address	seiryo-cho 1-1 aoba-ku sendai-si miyagi-ken
TEL	022-717-7321
Homepage URL
Email	tthsumida@yahoo.co.jp

Sponsor
Institute	Tohoku University Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization	Tohoku University Hospital Department of Anesthesiology
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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 01 Month 01 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	2015 Year 11 Month 15 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022864