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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000045707
Receipt No. R000052165
Scientific Title Exploratory study on relationship between antidepressant effects and changes in the intestinal environment due to Hangekobokuto administration.
Date of disclosure of the study information 2021/10/08
Last modified on 2021/10/08

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Basic information
Public title Exploratory study on relationship between antidepressant effects and changes in the intestinal environment due to Hangekobokuto administration.
Acronym Exploratory study on changes in the intestinal environment due to Hangekobokuto administration.
Scientific Title Exploratory study on relationship between antidepressant effects and changes in the intestinal environment due to Hangekobokuto administration.
Scientific Title:Acronym Exploratory study on changes in the intestinal environment due to Hangekobokuto administration.
Region
Japan

Condition
Condition Depressive symptoms
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate changes in the intestinal environment through increase of alpha-defensin secretion due to Hangekobokuto administration, and to examine the relationship between antidepressant effects and changes in the intestinal environment.
Basic objectives2 Others
Basic objectives -Others Changes in the amount of alpha-defensin secretion due to Hangekobokuto administration.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the amount of alpha-defensin secretion due to Hangekobokuto administration.
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 Taking the Kampo medicine (Hangekobokuto) for 2 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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria ・Subjects aged 20-74.
・Subjects whose Beck Depression Inventory - Second Edition score are between 14 to 28 points.
Key exclusion criteria ・Subjects undergoing depression treatment.
・Subjects who have taken Kampo medicines within the last 4 weeks.
・Subjects who have taken antibiotics within the last 4 weeks.
・Subjects who clearly need Western medical care.
・Subjects diagnosed with ulcerative colitis or Crohn's disease.
・Subjects with hepatic dysfunction or renal dysfunction.
・Subjects who participated in other clinical studies within 12 weeks before the start of study.
・Subjects judged by the attending physician to be ineligible.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Odaguchi
Organization Oriental Medicine Research Center, Kitasato University
Division name Center for Evidence-Based-Medicine
Zip code 108-8642
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-5791-6346
Email odaguchi@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Sekine
Organization Oriental Medicine Research Center, Kitasato University
Division name Center for Evidence-Based-Medicine
Zip code 108-8642
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-5791-6346
Homepage URL
Email omrc-ebm@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Innate Immunity Laboratory
Department of Cell Biological Science, Graduate School of Life Science, Faculty of Advanced Life Science, Hokkaido University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato Institute Hospital, Research Ethics Committee
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
Tel 03-3444-6161
Email kenkyu@insti.kitasato-u.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 北里大学東洋医学総合研究所(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 08 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
2021 Year 09 Month 08 Day
Date of IRB
2021 Year 09 Month 08 Day
Anticipated trial start date
2021 Year 11 Month 08 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 10 Month 08 Day
Last modified on
2021 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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