UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000019575