UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the effectiveness of Kikyo-To after tonsillectomy and adenoidectomy.
Title of the study (Brief title)	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	Tsuyoshi Maeda
Organization	Juntendo Univ. Urayasu Hospital
Division name	department of Anethesiology
Address	2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL	047-353-3111
Email	ichinimaeda@gmail.com

Public contact
Name of contact person	Tsuyoshi Maeda
Organization	Juntendo Univ. Urayasu Hospital
Division name	department of Anethesiology
Address	2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL	047-353-3111
Homepage URL
Email	ichinimaeda@gmail.com

Sponsor
Institute	Juntendo Univ.
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029253