UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial
Title of the study (Brief title)	Study of kikyo-to for upper respiratory tract infection (KURI)
Region	Japan

Condition
Condition	upper respiratory tract infection
Classification by specialty	Medicine in general Adult
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 10 minutes after kikyo-to is taken.
Key secondary outcomes	Secondary outcomes are the proportion of patients with sore throat score more than moderate level 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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients receive 2.5g herbal extract preparation of kikyo-to, a Japanese herbal medicine, desolved with a cup of hot water.
Interventions/Control_2	Patients receive 2.5g placebo (lactose), desolved with a cup 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 of upper respiratory tract infections with a complaint of sore throat, who visited a general internal medicine department office in the Akashi medical center hospital from December 2017 to June 2018 were registered.
Key exclusion criteria	Patients with allergy to kikyo-to and lactose, patients with aldosteronism, patients with myopathy, patients with known hypokalemia, pregnant patients or patients with possibility of pregnancy, breastfeeding patients, patients who take kikyo-to, patients inurgent condition, patients who were unable to participate the study because of dementia, visual impairment and unable to answer, or complete the study form.
Target sample size	70

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 27 Day
Anticipated trial start date	2017 Year 12 Month 01 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	2017 Year 12 Month 03 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034533