UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021451 |
|---|---|
| Receipt number | R000024739 |
| Scientific Title | The evaluation of the effect of keishibukuryogan on blood stagnation |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2024/09/17 09:46:19 |
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Basic information
Public title
The evaluation of the effect of keishibukuryogan on blood stagnation
Acronym
The evaluation of the effect of keishibukuryogan on blood stagnation
Scientific Title
The evaluation of the effect of keishibukuryogan on blood stagnation
Scientific Title:Acronym
The evaluation of the effect of keishibukuryogan on blood stagnation
Region
| Japan |
Condition
Condition
blood stagnation
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the feect of keishibukuryogan on patients with blood stagnation by measuring platelet function, score of blood stagnation, and peripheral circulation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of platelet aggregation between before, 2, 4, and 8 weeks after keishibukuryougan administration
Key secondary outcomes
The change of platelet function between before , 2, 4, and 8 weeks after keishibukuryougan administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of keishibukuryougan for 28 days.
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The score of blood stagnation is over 20.
No subjective symptom, drinking three times or less a week, and normal liver and renal function that has been confirmed in a medical examination within one year.
Key exclusion criteria
Any of the following: currently receiving a drug therapy, currently pregnant, and having and a history of anaphyraxy to keishibukuryogan.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Kanazawa University
Division name
Department of Kampo Medicine
Zip code
920-8641
Address
13-1,Takara-machi, Kanazawa
TEL
076-265-2918
okeiko@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Kanazawa University Hospital
Division name
Department of Kampo Medicine
Zip code
920-8641
Address
13-1 ,Takara-machi, Kanazawa
TEL
076-265-2918
Homepage URL
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Hospital
Address
13-1,Takara-machi, Kanazawa
Tel
076-265-2918
ikkandoo@gmail.com
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 | 03 | Month | 14 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
5
Results
none
Results date posted
| 2024 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
(1) Primary evaluation item
Measurement of aggregation ability using platelet particles (judged as effective if there is a change of 20% or more) [Reference 5]
(2) Secondary evaluation items
i) Platelet function evaluation (PAC-1, P-selectin, soluble CLEC2, etc.)
ii) Terasawa's blood stasis score (Table 1)
iii) Evaluation of peripheral circulation using O2C by LEA Medizintechnik (blood flow, blood flow velocity, peripheral oxygen saturation, relative hemoglobin content)
iv) Related toxicity after the start of Keishibukuryogan: Adverse events will be evaluated using the Japanese translation of the Common Terminology Criteria for Adverse Events v4.0 JCOG version [Reference 6], and blood tests, blood pressure and pulse measurements will also be performed.
v) The above evaluation items will be compared before and after Keishibukuryogan administration, and the correlation between each value will be examined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024739
