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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017332
Receipt No. 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

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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
Email 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
Email kkawagoh@yamanashi.ac.jp

Sponsor
Institute Tokyo Medical University Hachioji Medical Center Cardiovascular surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020107

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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