UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041301 |
|---|---|
| Receipt number | R000047163 |
| Scientific Title | A multicenter, observational study of Western and Kampo medicine treatment for mild and moderate COVID-19 patients (including suspected patients) to alleviate symptoms and reduce severity of disease |
| Date of disclosure of the study information | 2020/08/04 |
| Last modified on | 2023/07/24 16:23:05 |
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Basic information
Public title
An observational study of the treatment of patients with mild and moderate COVID-19 (including suspected patients)
Acronym
An observational study on the treatment of patients with mild and moderate COVID-19
Scientific Title
A multicenter, observational study of Western and Kampo medicine treatment for mild and moderate COVID-19 patients (including suspected patients) to alleviate symptoms and reduce severity of disease
Scientific Title:Acronym
An observational study on the treatment of patients with mild and moderate COVID-19
Region
| Japan |
Condition
Condition
COVID-19 patients(including suspected patients)
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retsospectively register the course of treatment with Western and Kampo medicines for patients with mild and moderate COVID-19 (including suspected patients), and to examine the associations regarding symptom relief and reduction of severity of the disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
symptom relief and reduction of severity of the disease
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COVID-19 patients (including suspected patiets)
Mild and moderate disease
Over 20 years old
Male and female
Can communicate in Japanese
Those who have been prescribed Western or Kampo medicines
Key exclusion criteria
Patients who have difficulty communicating and remembering due to dementia, psychosis or psychiatric symptoms
Severe illness (requires oxygen administration)
Other patients deemed unsuitable by the study physician
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takayama |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL
022-717-7507
takayama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwabara |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL
022-717-7507
Homepage URL
akiko.kuwabara.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital, Clinical Research Ethics Committee (Central Ethics Review Board) Office
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/62/2/62_0027-22/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/62/2/62_0027-22/_article
Number of participants that the trial has enrolled
962
Results
After performing propensity score matching and restricting the included cases to those with confirmed COVID-19 who did not receive steroid administration and initiated treatment within 4 days from the onset, the risk of illness worsening was significantly lower in the Kampo group than in the non-Kampo group (odds ratio=0.113, 95% confidence interval: 0.014-0.928, p=0.0424).
Results date posted
| 2023 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients in whom coronavirus disease 2019 (COVID-19) was suspected or confirmed between January 1, 2020, and October 31, 2021, were enrolled from Japanese hospitals in this multicenter, retrospective, observational study.
Data on the treatment administered (including conventional and Kampo medicine) and changes in common cold-like symptoms (such as fever, cough, sputum, dyspnea, fatigue, and diarrhea) were collected from their medical records.
Participant flow
Patients in whom coronavirus disease 2019 (COVID-19) was suspected or confirmed between January 1, 2020, and October 31, 2021, were enrolled from Japanese hospitals in this multicenter, retrospective, observational study.
Data on the treatment administered (including conventional and Kampo medicine) and changes in common cold-like symptoms (such as fever, cough, sputum, dyspnea, fatigue, and diarrhea) were collected from their medical records.
Adverse events
There were no significant differences between the groups.
Outcome measures
The primary outcome was the number of days without a fever (with a body temperature <37). The secondary outcomes were symptomatic relief and the worsening of illness, defined as the presence of a condition requiring oxygen inhalation. The outcomes of patients treated with and without Kampo medicine were compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047163
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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