UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008722 |
|---|---|
| Receipt number | R000010249 |
| Scientific Title | Pharmacokinetic study of fine granules of Kracie shoseiryuto extract in human blood |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2012/08/19 18:43:15 |
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Basic information
Public title
Pharmacokinetic study of fine granules of Kracie shoseiryuto extract in human blood
Acronym
Pharmacokinetic study of fine granules of Kracie shoseiryuto extract
Scientific Title
Pharmacokinetic study of fine granules of Kracie shoseiryuto extract in human blood
Scientific Title:Acronym
Pharmacokinetic study of fine granules of Kracie shoseiryuto extract
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the pharmacokinetics of fine granules of Kracie shoseiryuto extract with shoseiryuto standard decoction.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetic parameters of glycyrrhizic acid, Ephedrine, Pseudoephedrine, Paeoniflorin and their metabolites, and safety assessment of the fine granules
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 |
Interventions/Control_1
Administration of 6.0g fine granules of Kracie kakkonto extract with 270ml of water and 270mL of Kakkonto standard decoction 2 weeks afterward.
Interventions/Control_2
Administration of 270 mL of Kakkonto standard decoction and 6.0 g of fine granules of Kracie kakkonto extract with 270ml of water 2 weeks afterward.
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 give informed consent.
Key exclusion criteria
1.Those who donated blood during the past four months
2. Those who have a history of angina pectoris
3. Those who are suffering from dysuria
4. Those who are suffering from serious hepatic disorder, renal disease, heart disorder, pneumopathy or blood dyscrasias
5. Those who are taking supplements or vitamins on a regular basis.
6. Those who are judged by a medical doctor not eligible for the examination.
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
076-434-7617
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
TEL
076-434-7617
Homepage URL
Sponsor or person
Institute
Polyene Project , Ltd
Institute
Department
Personal name
Funding Source
Organization
Kracie Pharma, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 19 | Day |
Last modified on
| 2012 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010249
