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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023903
Receipt No. R000027527
Scientific Title Randomized controlled trial to reduce stress
Date of disclosure of the study information 2016/09/05
Last modified on 2016/09/02

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Basic information
Public title Randomized controlled trial to reduce stress
Acronym Randomized controlled trial to reduce stress
Scientific Title Randomized controlled trial to reduce stress
Scientific Title:Acronym Randomized controlled trial to reduce stress
Region
Japan

Condition
Condition NA
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of implementation of self-help stress care program and taking functional peptide-containing drink for six weeks
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stress reaction, administered before and after the trial (6W);
the Tension-Anxiety (TA), Depression (D), and Fatigue (F) subscales of the POMS
Key secondary outcomes Somatosensory Amplification Scale , Medical Symptom Checklist, General Self Efficacy Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Self-help stress care program and functional peptide drink for 6 weeks everyday
Interventions/Control_2 Self-help stress care program for 6 weeks everyday
Interventions/Control_3 Placebo program for 6 weeks everyday
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy males and females aged 20 years or more.
2) Subjects who can make self-judgment and agree to participate this trial.
Key exclusion criteria 1)Subjects who take continuous medical treatment.
2)Subjects who are pregnant or have possibility to become pregnant or planning to become pregnant during the study or breast-feeding woman.
3)Subjects who have allergic reaction to food.
4)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Abe
Organization Suntory Global Innovation Center Ltd.
Division name Innovation Development Department
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL 050-3182-0433
Email Keiichi_Abe@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nonaka
Organization Suntory Global Innovation Center Ltd.
Division name Innovation Development Department
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL 050-3182-0587
Homepage URL
Email Yuji_Nonaka@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Psychosomatic Medicine, Teikyo University Hospital, Teikyo University School of Medicine
Faculty of Human Sciences, Musashino University
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
2016 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.facebook.com/wcpmglasgow/
Number of participants that the trial has enrolled
Results
The self-help CCBT program reduced the subjective experience of tension-anxiety in workers. The addition of a supplement drink enhanced the effect of CCBT on fatigue, providing one possible approach to enhancement of such programs.
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 Main results already published
Date of protocol fixation
2014 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 24 Day
Last follow-up date
2014 Year 11 Month 28 Day
Date of closure to data entry
2014 Year 12 Month 15 Day
Date trial data considered complete
2015 Year 01 Month 20 Day
Date analysis concluded
2015 Year 01 Month 20 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2016 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027527

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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