UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030942 |
|---|---|
| Receipt number | R000035309 |
| Scientific Title | Verification of the therapeutic effect of a multidisciplinary treatment strategy for chronic fatigue syndrome |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/01/25 09:12:17 |
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Basic information
Public title
Verification of the therapeutic effect of a multidisciplinary treatment strategy for chronic fatigue syndrome
Acronym
Kampo therapy and Psychotherapy for chronic fatigue syndrome
Scientific Title
Verification of the therapeutic effect of a multidisciplinary treatment strategy for chronic fatigue syndrome
Scientific Title:Acronym
Kampo therapy and Psychotherapy for chronic fatigue syndrome
Region
| Japan |
Condition
Condition
chronic fatigue syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of multidisciplinary treatment combining Kampo treatment and psychotherapy for patients with chronic fatigue syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Performance Status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kampo therapy and psychotherapy, 6 months
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic fatigue syndrome patients who visit Nagoya University Hospital
Key exclusion criteria
1)Patients with other physical disorders
2)Patients with other mental illnesses
3)People who are judged to have a strong physical burden of receiving psychotherapy
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoki Sato |
Organization
Nagoya University Hospital
Division name
General Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2951
samotoki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Sato |
Organization
Nagoya University Hospital
Division name
General Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2951
Homepage URL
samotoki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035309
