UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048389 |
|---|---|
| Receipt number | R000055155 |
| Scientific Title | Effects of Kampo medicines on the prevention of COVID-19 |
| Date of disclosure of the study information | 2023/12/24 |
| Last modified on | 2023/09/13 09:42:48 |
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Basic information
Public title
Effects of Kampo medicines on the prevention of COVID-19
Acronym
Prevention of COVID-19 with Kampo medicines
Scientific Title
Effects of Kampo medicines on the prevention of COVID-19
Scientific Title:Acronym
Prevention of COVID-19 with Kampo medicines
Region
| Japan |
Condition
Condition
Coronavirus disease 2019
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of prevention of Kampo Medicines to COVID-19
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
onset after exposure to infection
Key secondary outcomes
Worsening after onset of infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Someone which has Kampo medicines (5days, 7.5g/day)
Interventions/Control_2
Someone which has no Kampo medicines
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Someone which want to have Kampo medicines after exposure to COVID-19 for prevention
Key exclusion criteria
Someone which has a history of side effects to Kampo medicines
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Chiba |
Organization
Sapporo Suzuki Hospital
Division name
Department of Internal Medicine
Zip code
001-0903
Address
Kita-ku
TEL
0117095511
chibas_0317@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Chiba |
Organization
Sapporo Suzuki Hospital
Division name
Department of Internal Medicine
Zip code
001-0903
Address
1-27, Shinkotoni-3jo-1chome, Kita-ku, Sapporo, Hokkaido
TEL
0117095511
Homepage URL
chibas_0317@yahoo.co.jp
Sponsor or person
Institute
Department of Internal Medicine, Sapporo Suzuki Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Sapporo Suzuki Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Suzuki Hospital
Address
1-27, Shinkotoni-3jo-1chome, Kita-ku, Sapporo, Hokkaido, 001-0903
Tel
0117095511
chibas_0317@yahoo.co.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
札幌鈴木病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This trial was accepted for Respiratory Investigation on July 18, 2023.
Chiba S, Shinohara K. Keigai-rengyo-to as post-exposure prophylaxis for severe acute respiratory syndrome coronavirus 2. Respir Investig. 2023;61:669-674
Management information
Registered date
| 2022 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
