UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044318 |
|---|---|
| Receipt number | R000050618 |
| Scientific Title | Survey on the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae. |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2023/12/01 15:30:16 |
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Basic information
Public title
Survey on the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae.
Acronym
Survey on the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae.
Scientific Title
Survey on the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae.
Scientific Title:Acronym
Survey on the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae.
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Kampo treatment in patients with COVID-19 related sequelae.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Evaluation scale for health related quality of life (SF-12)
･Visual analogue scale (VAS) in each symptom
･Five-grade evaluation in overall treatment efficacy
･Safety evaluation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients with COVID-19 related sequelae.
･Patients with a history of COVID-19.
･Patients with symptoms due to COVID-19 related sequelae for more than 1 month after infection or onset.
･Patients who have given informed consent.
Key exclusion criteria
･Patients under the age of 20.
･Patients judged by the attending physician to be ineligible.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Ito |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Oriental Medicine Therapy Center
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6346
ito-h@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Sekine |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6346
Homepage URL
omrc-ebm@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japan Society for Oriental Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
Tel
03-3444-6161
kenkyu@insti.kitasato-u.ac.jp
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
北里大学東洋医学総合研究所（東京都）、北里大学病院（神奈川県）、東北大学病院（宮城県）、富山大学附属病院（富山県）、千葉大学医学部附属病院（千葉県）、横浜市立大学附属病院（神奈川県）、福島県立医科大学 会津医療センター（福島県）、東海大学医学部付属病院（神奈川県）、医療法人社団創友会ヒラハタクリニック（東京都）、東京医科大学病院（東京都）、証クリニック神田（東京都）、東京都立墨東病院（東京都）、湘南病院（神奈川県）、慶應義塾大学病院（東京都）予定
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 25 | 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
134
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study that evaluates the efficacy of Kampo treatment in patients with COVID-19 related sequelae by comparing the Kampo taking group with the Kampo non-taking group.
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050618
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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