UMIN-CTR Clinical Trial

Basic information
Public title	Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a multicenter, randomized, controlled trial
Acronym	Multicenter study of kikyo-to for upper respiratory tract infection (mKURI)
Scientific Title	Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a multicenter, randomized, controlled trial
Scientific Title:Acronym	Multicenter study of kikyo-to for upper respiratory tract infection (mKURI)
Region	Japan

Condition
Condition	upper respiratory tract infection
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy of kikyo-to on sore throat pain associated with acute URTI compared with a placebo.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is the difference on sore throat VAS scale between 30 minutes after kikyo-to is taken.
Key secondary outcomes	Primary outcome is the difference of sore throat VAS scale between 10 minutes after kikyo-to is taken.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients receive 2.5 g herbal extract preparation of kikyo-to, a Japanese herbal medicine, dissolved in 100 mL of hot water.
Interventions/Control_2	Patients receive a 2.5 g placebo (lactose), dissolved in 100 mL of hot water.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with upper respiratory tract infections and a complaint of sore throat, aged >= 20 and < 65 years were registered.
Key exclusion criteria	Allergy to kikyo-to or lactose, aldosteronism, myopathy, known hypokalemia, pregnancy or possibility of pregnancy, breastfeeding, current usage of kikyo-to, inurgent condition, unable to participate in the study because of dementia, visual impairment, unable to answer or complete the study form
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoto Ishimaru
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code
Address	743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL	0789361101
Email	maru-tkb@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Hirata
Organization	Akashi Medical Center
Division name	Department of Medical Quality and Safety
Zip code
Address	743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL	0789361101
Homepage URL
Email	yakuzaika.2@amc1.jp

Sponsor
Institute	Akashi Medical Center
Institute
Department

Funding Source
Organization	AIJINKAI Healthcare Corporation
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
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	社会医療法人愛仁会明石医療センター、利根保健生活協同組合利根中央病院

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 21 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	Completed
Date of protocol fixation	2018 Year 12 Month 19 Day
Date of IRB	2018 Year 12 Month 19 Day
Anticipated trial start date	2019 Year 02 Month 05 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 18 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040377