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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009334
Receipt No. R000010878
Scientific Title Blood pharmacokinetic study on fine-granulated of Kracie hachimijiogan ryo extract in humans
Date of disclosure of the study information 2012/11/15
Last modified on 2013/05/15

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Basic information
Public title Blood pharmacokinetic study on fine-granulated of Kracie hachimijiogan ryo extract in humans
Acronym Blood pharmacokinetic study on fine-granulated of Kracie hachimijiogan ryo extract
Scientific Title Blood pharmacokinetic study on fine-granulated of Kracie hachimijiogan ryo extract in humans
Scientific Title:Acronym Blood pharmacokinetic study on fine-granulated of Kracie hachimijiogan ryo extract
Region
Japan

Condition
Condition none
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare pharmacokinetics of fine-granulated hachimijiogan ryo extract of Kracie with standard decoction of hachimijiogan ryo.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetic parameters of Loganin, Paeoniflorin and their metabolites, and safety assessment of their fine-granulated extracts.
Key secondary outcomes none

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Maneuver
Interventions/Control_1 Administration of 6.0 g fine-granulated hachimijiogan ryo extract of Kracie with 220 ml of water, and 2 weeks afterward 220 mL standard decoction of hachimijiogan ryo .
Interventions/Control_2 Administration of 220 mL standard decoction of hachimijiogan ryo, and 2 weeks afterward 6.0 g fine-granulated hachimijiogan ryo extract of Kracie with 220 ml of water.
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
65 years-old >=
Gender Male
Key inclusion criteria Healthy male volunteers between 20 and 65 years of age who have given informed consent.
Key exclusion criteria 1. Those who donated blood during the past four months
2. Those who are sturdy.
3. Those who are sensitive to the heat, liable to have a rush of blood to the head, and have ruddy face.
4. Those who suffer from extremely poor digestion.
5. Those who suffer from poor appetite, nausea, and/or vomiting.
6. Those who suffer from serious diseases of liver, kidney, heart, lung or blood.
7. Those who take supplements or vitamins on a regular basis.
8. Those who physicians in charge judge not to be appropriate for the study.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Hamazaki
Organization Polyene Project , Ltd
Division name Dept of Clinical Science
Zip code
Address Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL 076-432-0876
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Hamazaki
Organization Polyene Project , Ltd
Division name Dept of Clinical Science
Zip code
Address Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL 076-432-0876
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 National Institute of Health Sciences
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 清幸会 島田病院

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 15 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
2012 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 16 Day
Last follow-up date
2012 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 15 Day
Last modified on
2013 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010878

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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