UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017332 |
|---|---|
| Receipt number | R000020107 |
| Scientific Title | Effective and safe examination of Tsumura-hachimijiogan extract granule(Ethical) for the peripheral arterial disease |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2017/04/30 09:05:19 |
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Basic information
Public title
Effective and safe examination of Tsumura-hachimijiogan extract granule(Ethical) for the peripheral arterial disease
Acronym
Hachimijiogan study
Scientific Title
Effective and safe examination of Tsumura-hachimijiogan extract granule(Ethical) for the peripheral arterial disease
Scientific Title:Acronym
Hachimijiogan study
Region
| Japan |
Condition
Condition
peripheral arterial disease(PAD)
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Statistical study for clinical effect of hatimijiogan to the patient of peripheral arterial disease(PAD) by administration of Tsumura hatimijiogan extract granule (Ethical)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking Impairment Questionnaire(WIQ) as assessment of claudication severity
ABI and SPP as an indication for ischemia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tsumura-hatimijiogan extract granule (Ethical)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patient with intermittent claudication and ABI under 0.9
Key exclusion criteria
the patients with critical comorbidity (liver disease, kidney disease, heart disease, blood disease, or metabolic disease), patients administered or going to be administered medicine under development, and patients administered or going to be administered other Chinese medicine.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Kawago |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Cardiovascular surgery
Zip code
Address
1163, Tachimachi, Hachioji-shi, Tokyo
TEL
042-665-5611
kkawagoh@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kawago |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Cardiovascular surgery
Zip code
Address
1163, Tachimachi, Hachioji-shi, Tokyo
TEL
042-665-5611
Homepage URL
kkawagoh@yamanashi.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center Cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hachioji Medical Center Cardiovascular surgery
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 30 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 25 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2017 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020107
