UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035591 |
|---|---|
| Receipt number | 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 | 2019/12/25 15:59:48 |
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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
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
yakuzaika.2@amc1.jp
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040377
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
