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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001532
Receipt No. R000001849
Scientific Title The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study
Date of disclosure of the study information 2008/11/28
Last modified on 2009/06/24

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Basic information
Public title The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study
Acronym The effect of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue
Scientific Title The effects of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue --- A placebo-controlled, double-blind study
Scientific Title:Acronym The effect of Keishi-bukuryo-gan-ryo-ka-yokuinin on fatigue
Region
Japan

Condition
Condition Easy fatigability
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test whether the administration of Keishi-bukuryo-gan-ryo-ka-yokuinin (KBKY) ameliorates fatigue, and to measure changes in cerebral blood and in blood levels of the followings after KBKY administration (progesterone, estrogen, fatty acids, TGF-beta, herpes virus, cytokine and Brain-derived neurotrophic factor).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes in fatigue levels measured with the POMS test 4 weeks after KBKY administration.
Key secondary outcomes After 4 weeks of KBKY administration, we will measure fatigue-related materials in blood, female hormones, cerebral blood flow, facial skin contents of oil and water, autonomous nervous system, and the frontal-lobe-related functions (Krepelin test and questionnaires measuring concentration, motivation, calculation (planning), and alertness); also we will check whether subjects put their houses (living rooms etc.) in order.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Four tablets of KBKY, twice a day (8 tablets as a total), for 4 weeks; in the case of women, from the beginning of menstruation to the next menstruation.
Interventions/Control_2 Four placebo tablets, twice a day (8 tablets as a total), for 4 weeks; in the case of women, from the beginning of menstruation to the next menstruation.
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
50 years-old >
Gender Male and Female
Key inclusion criteria Normal volunteers of 20-50 years of age
Key exclusion criteria Those who have histories of or are suffering from serious diseases or metabolic/endocrine diseases.
Those who are allergic to KBKY.
Those of frail constitution.
Menopausal women.
Those who are pregnant, lactating or planning to be pregnant.
Those who are not suitable for the study according to the doctors in charge of this trial.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Hamazaki
Organization Polyene Project, Ltd.
Division name Section of Clinical Application, Dept of Clinical Science
Zip code
Address Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL 076-432-8760
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Hamazaki
Organization Polyene Project, Ltd.
Division name Section of Clinical Application, Dept of Clinical Science
Zip code
Address Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL 076-432-8760
Homepage URL
Email keihama@med.u-toyama.ac.jp

Sponsor
Institute Polyene Project, Ltd.
Institute
Department

Funding Source
Organization Kracie Pharma, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 11 Month 28 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 Completed
Date of protocol fixation
2008 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 28 Day
Last modified on
2009 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001849

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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