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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035591
Receipt No. R000040377
Scientific Title Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a multicenter, randomized, controlled trial
Date of disclosure of the study information 2019/01/21
Last modified on 2019/02/14

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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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 05 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
2019 Year 01 Month 18 Day
Last modified on
2019 Year 02 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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