Unique ID issued by UMIN | UMIN000012540 |
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Receipt number | R000014380 |
Scientific Title | Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza. |
Date of disclosure of the study information | 2013/12/20 |
Last modified on | 2014/01/07 11:36:46 |
Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza.
Kampo Therapy Decision Making Model for Influenza.
Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza.
Kampo Therapy Decision Making Model for Influenza.
Japan |
Influenza like illness
Infectious disease |
Others
NO
To assess a decision making model including Kampo therapy for the management of influenza.
Safety,Efficacy
Confirmatory
Not applicable
Patients' choice of therapy (Primary outcome about medical cost)
Duration of fever (Primary outcome about effectiveness)
Change of therapy
Initial symptoms
Dose of antipyretics
Adverse event
Patients' satisfaction for treatment
Vaccination
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Medicine |
Neuraminidase inhibitors including osertamivir, zanamivir, and laninamivir
Kampo formula including maoto for patinets with sweating and makyokansekito for without sweating
watchful waiting
20 | years-old | <= |
65 | years-old | >= |
Male and Female
patients with influenza like illness who meet all the requirements below
1. axilla temperature equal or higher than 38.0 degree C within the first 48 hours after the onset of fever
2. some symptoms shown below
chill
sore throat
cough
headache
muscle pain
multiple arthrargia
general fatigue
1. patients younger than 19 year-old or older than 65 year-old
2. patients with slight symptoms like subfever or running nose only
3. patients with severe symptoms which need hospitalization
4. persons with chronic pulmonary (including asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (including sickle cell disease), metabolic disorders (including diabetes mellitus), or neurologic and neurodevelopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury), and active hyperthyroidism
5. patients in danger of urinary retention
6. persons with immunosuppression, including that caused by medications or by HIV infection
7. women who are pregnant or postpartum (within 2 weeks after delivery)
8. persons who are morbidly obese (i.e., body-mass index is equal to or greater than 40)
9. residents of nursing homes and other chronic-care facilities
10. patients considered inappropriate for this trial by the physicians-in-charge including allergic reaction to the test drugs
300
1st name | |
Middle name | |
Last name | Masashi Mimura |
Keio University School of Medicine
Center for Kampo Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5366-3824
mimura@a7.keio.jp
1st name | |
Middle name | |
Last name | Tetsuhiro Yoshino |
Keio University School of Medicine
Center for Kampo Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5366-3824
http://www.keio-kampo.jp/index.html
tetta213@a5.keio.jp
Keio University School of Medicine
Keio University School of Medicine
Self funding
Kobe University Hospital
Jichi Medical University Hospital
Nishitaga National Hospital
Hiyoshi Medical Clinic
Irako Clinic
Ohi Kyodo Clinic
Kameda Medical Hospital
Ohsaki First Clinic
Saiseikai Central Hospital
Saiseikai Mukoujima Hospital
Kumamoto Red Cross Hospital
NO
慶應義塾大学病院漢方医学センター (主幹施設:東京都)
神戸大学病院(兵庫県)
自治医科大学付属病院(栃木県)
国立病院機構西多賀病院漢方医学センター(宮城県)
日吉メディカルクリニック(神奈川県)
五十子クリニック(東京都)
大井協同診療所(東京都)
亀田総合病院(千葉県)
大崎ファーストクリニック(東京都)
東京都済生会中央病院(東京都)
東京都済生会向島病院(東京都)
熊本赤十字病院(熊本県)
2013 | Year | 12 | Month | 20 | Day |
Unpublished
Terminated
2013 | Year | 12 | Month | 20 | Day |
2013 | Year | 12 | Month | 20 | Day |
2013 | Year | 12 | Month | 10 | Day |
2014 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014380
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