UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050726 |
|---|---|
| Receipt number | R000057796 |
| Scientific Title | Effects of Kampo medicines on the persistent cough of long COVID-19 |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2024/09/14 08:52:08 |
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Basic information
Public title
Effects of Kampo medicines on the persistent cough of long COVID-19
Acronym
Improvement of post-COVID-19 prolonged cough with Kampo medicines
Scientific Title
Effects of Kampo medicines on the persistent cough of long COVID-19
Scientific Title:Acronym
Improvement of post-COVID-19 prolonged cough 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 improvement of Kampo Medicines to long COVID-19 (respiratory symptom)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of cough score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chikujountanto(CUT) group (at least 7days, 7.5g/day). Consecutive participants who met the eligibility criteria were alternatively assigned to the CUT(Intervention_1) and BT groups(Intervention_2). Both groups received concomitant inhalation therapy (inhaled corticosteroid plus a long-acting beta 2 agonist: ICS/LABA).
Interventions/Control_2
bakumondoto(BT) group (at least 7days, 9.0g/day). Consecutive participants who met the eligibility criteria were alternatively assigned to the CUT(Intervention_1) and BT groups(Intervention_2). Both groups received concomitant inhalation therapy (inhaled corticosteroid plus a long-acting beta 2 agonist: ICS/LABA).
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
Someones which want to have Kampo medicines for post-COVID-19 prolonged cough (CUT or BT)
i) age 20 years or over; ii) a SARS-CoV-2 test was positive; iii) SpO2 96% or over; and iv) after antivirals, inhalation (inhaled corticosteroid plus a long-acting beta 2 agonist: ICS/LABA) and adjuvant therapy (bronchodilators)
Key exclusion criteria
Someone which has a history of side effects to Kampo medicines and the following conditions
1) history of asthma; 2) incidence of self-reported wheezing, pharmacy data indicating asthma-like symptoms or variability in lung function in the previous year; 3) current treatment that could influence cough; 4) any concurrent airway disease (eg pneumonia, cancer); and 5) uncontrolled systemic disease or pregnancy
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
1-27, Shinkotoni-3jo-1chome, 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
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
Self funding
Nationality of Funding Organization
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
+81117095511
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/tkm2.1425
Number of participants that the trial has enrolled
56
Results
This study was accepted by Traditional & Kampo Medicine on 22 August 2024.
Chiba S, Shinohara K. Persistent cough in mild COVID-19 successfully treated with chikujountanto, a traditional Kampo medicine: An observational cohort study. Tradit Kampo Med. 2024; 1-8. doi: 10.1002/tkm2.1425
Results date posted
| 2024 | Year | 08 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057796
