UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016865 |
|---|---|
| Receipt number | 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 17:47:53 |
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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
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
takayama@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019575
