Unique ID issued by UMIN | UMIN000042486 |
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Receipt number | R000048495 |
Scientific Title | Study for the effectiveness of drug therapy for orthostatic dysregulation in children |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2023/11/20 10:33:00 |
Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Japan |
Orthostatic Dysregulation
Pediatrics |
Others
NO
To evaluate the effectiveness of Hangebyakujutenmato for orthostatic dysregulation
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Improvement rate of subjective symptom visual analogue scale (VAS) score
Incidence of Adverse Events, Blood Pressure and Pulse in New Orthostatic Test
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
No need to know
2
Treatment
Medicine |
Group A receives Hangebyakujutenmato in the I stage and midodrine hydrochloride in the II stage. Phase I and Phase II are 4 weeks each. There will be a 2-4 week washout period between Phase I and Phase II.
Group B receives midodrine hydrochloride in stage I and Hangebyakujutenmato in stage II. Phase I and Phase II are 4 weeks each. There will be a 2-4 week washout period between Phase I and Phase II.
7 | years-old | <= |
18 | years-old | > |
Male and Female
When all of the following are satisfied
1) Persons who have obtained written consent for participation in the research
2) 7 years old or older and under 18 years old at the time of obtaining consent
3) Those who have been diagnosed with orthostatic dysregulation by a doctor and whose symptoms are not improved by non-drug therapy
When one or more of the following are satisfied
1) Those who cannot discontinue other treatments that may affect the symptoms of orthostatic dysregulation
2) Those who suffering from acute diseases such as upper respiratory tract inflammation and acute gastroenteritis
3) Those who cannot exclude underlying diseases other than orthostatic dysregulation
4) Those who have difficulty communicating
5) Others who the principal investigator deems inappropriate as a subject
40
1st name | Koji |
Middle name | |
Last name | Nishimura |
Saijo central hospital
Pediatrics
793-0027
804, Tsuitachi, Saijo, Ehime
0897560300
break_down@hotmail.co.jp
1st name | Koji |
Middle name | |
Last name | Nishimura |
Saijo central hospital
Pediatrics
793-0027
804, Tsuitachi, Saijo, Ehime
0897560300
http://www.saijo-c-hospital.jp/
break_down@hotmail.co.jp
Saijo central hospital
none
Other
Saijo central hospital
804, Tsuitachi, Saijo, Ehime
0897560300
break_down@hotmail.co.jp
NO
西条中央病院
2020 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2020 | Year | 06 | Month | 16 | Day |
2020 | Year | 06 | Month | 26 | Day |
2020 | Year | 12 | Month | 01 | Day |
2025 | Year | 11 | Month | 30 | Day |
2020 | Year | 11 | Month | 17 | Day |
2023 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048495
Research Plan | |
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Registered date | File name |
2023/05/22 | ★★OD研究計画書★★.docx |
Research case data specifications | |
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Registered date | File name |
2023/05/22 | ⑤OD-CRF(症例報告書).docx |
Research case data | |
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Registered date | File name |