UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056167 |
|---|---|
| Receipt number | R000064177 |
| Scientific Title | Investigation into the efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for post COVID-19 condition |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2024/11/18 10:05:34 |
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Basic information
Public title
Investigation into the efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for post COVID-19 condition
Acronym
Investigation into the efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for post COVID-19 condition
Scientific Title
Investigation into the efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for post COVID-19 condition
Scientific Title:Acronym
Investigation into the efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for post COVID-19 condition
Region
| Japan |
Condition
Condition
post COVID-19 condition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether Kampo ( Japanese traditional herbal medicine ) treatment is effective for post COVID-19 condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of Kampo ( Japanese traditional herbal medicine ) treatment for general malaise, the most important post COVID-19 condition
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
History of COVID-19 and 16 symptoms
Key exclusion criteria
No history of COVID-19
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kawamura |
Organization
Hachinohe City Hospital
Division name
Department of Kampo Medicine
Zip code
031-8555
Address
3-1-1 Tamukai, Hachinohe City, Aomori Prefecture, Japan
TEL
+81-178-72-5180
kwtsuyo0106.icloud@icloud.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kawamura |
Organization
Hachinohe City Hospital
Division name
Department of Kampo Medicine
Zip code
031-8111
Address
3-1-1 Tamukai, Hachinohe City, Aomori Prefecture, Japan
TEL
+81-178-72-5111
Homepage URL
kwtsuyo0106.icloud@icloud.com
Sponsor or person
Institute
Hachinohe City Hospital
Institute
Department
Personal name
Tsuyoshi Kawamura
Funding Source
Organization
Hachinohe City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Kampo and Integrative Medicine,Tohoku University Graduate School of Medicine
Name of secondary funder(s)
Department of Kampo and Integrative Medicine,Tohoku University Graduate School of Medicine
IRB Contact (For public release)
Organization
Ethics Committee of Hachinohe City Hospital
Address
3-1-1 Tamukai, Hachinohe City, Aomori Prefecture, Japan
Tel
+81-178-72-5111
senmon-kensyu@hospital.hachinohe.aomori.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
八戸市立市民病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 18 | 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
128
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Patients were asked to describe their performance status (PS, 0-9, higher values indicate more severe fatigue)11,12) and 16 symptoms on a numerical rating scale (NRS, 0-10) using the check sheets at each visit. PS scale had been used for evaluating the extent of fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in Japa
Management information
Registered date
| 2024 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064177
