UMIN-CTR Clinical Trial

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
Email	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
Email	samotoki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035309