UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019793 |
|---|---|
| Receipt number | 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 11:01:10 |
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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
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
tthsumida@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022864
