Unique ID issued by UMIN | UMIN000035591 |
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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 |
Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a multicenter, randomized, controlled trial
Multicenter study of kikyo-to for upper respiratory tract infection (mKURI)
Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a multicenter, randomized, controlled trial
Multicenter study of kikyo-to for upper respiratory tract infection (mKURI)
Japan |
upper respiratory tract infection
Medicine in general |
Others
NO
We investigate the efficacy of kikyo-to on sore throat pain associated with acute URTI compared with a placebo.
Efficacy
Confirmatory
Pragmatic
Not applicable
Primary outcome is the difference on sore throat VAS scale between 30 minutes after kikyo-to is taken.
Primary outcome is the difference of sore throat VAS scale between 10 minutes after kikyo-to is taken.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Patients receive 2.5 g herbal extract preparation of kikyo-to, a Japanese herbal medicine, dissolved in 100 mL of hot water.
Patients receive a 2.5 g placebo (lactose), dissolved in 100 mL of hot water.
20 | years-old | <= |
65 | years-old | > |
Male and Female
Patients with upper respiratory tract infections and a complaint of sore throat, aged >= 20 and < 65 years were registered.
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
70
1st name | |
Middle name | |
Last name | Naoto Ishimaru |
Akashi Medical Center
Department of General Internal Medicine
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
0789361101
maru-tkb@umin.ac.jp
1st name | |
Middle name | |
Last name | Tomoko Hirata |
Akashi Medical Center
Department of Medical Quality and Safety
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
0789361101
yakuzaika.2@amc1.jp
Akashi Medical Center
AIJINKAI Healthcare Corporation
Other
NO
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
2019 | Year | 01 | Month | 21 | Day |
Unpublished
Completed
2018 | Year | 12 | Month | 19 | Day |
2018 | Year | 12 | Month | 19 | Day |
2019 | Year | 02 | Month | 05 | Day |
2019 | Year | 12 | Month | 25 | Day |
2019 | Year | 01 | Month | 18 | Day |
2019 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040377
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