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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016865
Receipt No. R000019575
Scientific Title Preliminary study of the effect of tokishakuyakusan on ocular blood flow in the patients with normal tension glaucoma
Date of disclosure of the study information 2015/03/21
Last modified on 2019/04/03

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Basic information
Public title Preliminary study of the effect of tokishakuyakusan on ocular blood flow in the patients with normal tension glaucoma
Acronym The effect of tokishakuyakusan on ocular blood flow in the patients with normal tension glaucoma
Scientific Title Preliminary study of the effect of tokishakuyakusan on ocular blood flow in the patients with normal tension glaucoma
Scientific Title:Acronym The effect of tokishakuyakusan on ocular blood flow in the patients with normal tension glaucoma
Region
Japan

Condition
Condition normal tension glaucoma
Classification by specialty
Cardiology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the change of condition including ocular blood flow in normal tension glaucoma with adding tokishakuyakusan to conventional therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ocular blood flow
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 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 Traditional Japanese Kampo medicine tokishakuyakusan (TJ-23), 7.5g/day, orally, for 6 months
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
60 years-old >
Gender Female
Key inclusion criteria 1. systolic blood pressure < 130 mmHg and systolic blood pressure < 85 mmHg
2. intra ocular pressure <= 21 mmHg
3. with no significant abnormality in an examination for slit lamp microscopy and angle
4. with glaucoma-related optic disc shape in funduscopy
5. with glaucoma-related field change by at least two times of reliable visual field tests
6. written informed consent can be obtained from the participant
Key exclusion criteria 1. When there is hypotension, circulatory disease, endocrine disease, a cause including excessive anemia are identified, and the cause is judged if treatment is necessary.
2. pregnant
3. history of allergy to Kampo medicine
4. history of unpleasantness, gastrointestinal disorder by the Kampo medicine
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Takayama
Organization Tohoku University Graduate School of Medicine
Division name Comprehensive Education Center for Community Medicine
Zip code 981-8575
Address 2-1, Seiryo-machi, Aoba ward, Sendai 980-8575, Japan
TEL 022-717-8010
Email takayama@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Shin
Middle name
Last name Takayama
Organization Tohoku University Graduate School of Medicine
Division name Comprehensive Education Center for Community Medicine
Zip code 981-8575
Address 2-1, Seiryo-machi, Aoba ward, Sendai 980-8575, Japan
TEL 022-717-8010
Homepage URL
Email takayama@med.tohoku.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

Funding Source
Organization JSPS
KAKEN
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization MHLW Certified Clinical Research Review Board, Tohoku University
Address 2-1-1, Katahira, Aoba ward, Sendai city
Tel 022-718-0461
Email office@nrs.hosp.tohoku.ac.jp

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 03 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 12
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Writing the manuscript
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
2014 Year 10 Month 16 Day
Date of IRB
2014 Year 10 Month 16 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 21 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019575

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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