Unique ID issued by UMIN | UMIN000030239 |
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Receipt number | R000034533 |
Scientific Title | Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial |
Date of disclosure of the study information | 2017/12/04 |
Last modified on | 2019/01/18 17:58:02 |
Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial
Study of kikyo-to for upper respiratory tract infection (KURI)
Effects of kikyo-to on sore throat pain associated with acute upper respiratory tract infection: a randomized, controlled trial
Study of kikyo-to for upper respiratory tract infection (KURI)
Japan |
upper respiratory tract infection
Medicine in general | Adult |
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 10 minutes after kikyo-to is taken.
Secondary outcomes are the proportion of patients with sore throat score more than moderate level between 10 minutes after kikyo-to is taken.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Patients receive 2.5g herbal extract preparation of kikyo-to, a Japanese herbal medicine, desolved with a cup of hot water.
Patients receive 2.5g placebo (lactose), desolved with a cup of hot water.
20 | years-old | <= |
65 | years-old | > |
Male and Female
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.
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.
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 | 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
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
2017 | Year | 12 | Month | 04 | Day |
Unpublished
Completed
2017 | Year | 10 | Month | 27 | Day |
2017 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 03 | Day |
2019 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034533
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