UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025439 |
|---|---|
| Receipt number | R000029253 |
| Scientific Title | The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy. |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2016/12/27 18:39:25 |
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Basic information
Public title
The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Acronym
The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Scientific Title
The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Scientific Title:Acronym
The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Region
| Japan |
Condition
Condition
tonsil hypertrophy
IgA nephropathy
chronic tonsillitis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effectiveness of Kikyo-To
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS
Key secondary outcomes
CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
take Kikyo-to 7.5g/day.
Interventions/Control_2
take Kikyo-to for 2days after operation.
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1-2
Key exclusion criteria
ASA>3
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Maeda |
Organization
Juntendo Univ. Urayasu Hospital
Division name
department of Anethesiology
Zip code
Address
2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL
047-353-3111
ichinimaeda@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Maeda |
Organization
Juntendo Univ. Urayasu Hospital
Division name
department of Anethesiology
Zip code
Address
2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL
047-353-3111
Homepage URL
ichinimaeda@gmail.com
Sponsor or person
Institute
Juntendo Univ.
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 12 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | 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
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029253
