UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019038 |
|---|---|
| Receipt number | R000020724 |
| Scientific Title | Efficacy of Jidaboku-Ippo for postoperative pain treatment |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2018/03/25 11:11:30 |
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Basic information
Public title
Efficacy of Jidaboku-Ippo for postoperative pain treatment
Acronym
Jidaboku-Ippo for postoperative pain
Scientific Title
Efficacy of Jidaboku-Ippo for postoperative pain treatment
Scientific Title:Acronym
Jidaboku-Ippo for postoperative pain
Region
| Japan |
Condition
Condition
Patient who undergo oral surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Jidaboku-Ippo for postoperative pain management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain
Additional postoperative analgesics
Patient sufficiency
Key secondary outcomes
nause vomit
wound healing
wound expansion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative administration of Jidaboku-Ippo
Interventions/Control_2
Preoperative administration of Jidaboku-Ippo
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who undergo oral surgery under general anesthesia
Key exclusion criteria
Patient for emergency medicine
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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 | 09 | Month | 16 | 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
Upon recovery and 1 hour from anesthesia, NRS scores did not significantly differ between the two groups. After 3 hour and 24 hour from recovery of anesthesia, the NRS score was significantly lower in the JDI group than in the control group (P<0.001). Moreover, the amount of NSAID administered within 24 hours after surgery was significantly higher in the control group than in the JDI group (P<0.001).
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 | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 26 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 26 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 26 | Day |
Other
Other related information
During the follow-up period, the severity of nausea differed significantly between the two groups.
No significant side effects related to JDI, such as edema, hepatic impairment, interstitial pneumonia, or hypokalemia, were noted during the clinical trial.
Demographic data were similar between the two groups.
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020724
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
