UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019793
Receipt No. R000022864
Scientific Title The effect of the Goreisan prophylaxis on headache after the cesarean operation
Date of disclosure of the study information 2015/11/20
Last modified on 2017/05/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of the Goreisan prophylaxis on headache after the cesarean operation
Acronym Goreisan prophylaxis
Scientific Title The effect of the Goreisan prophylaxis on headache after the cesarean operation
Scientific Title:Acronym 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
1st name
Middle name
Last name Masanori Yamauchi
Organization Tohoku University Hospital
Division name Department of Anesthesiology
Zip code
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
1st name
Middle name
Last name Hiroshi Sumida
Organization Tohoku University
Division name Department of Anesthesiology
Zip code
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)

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 11 Month 20 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 Terminated
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.