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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002254
Receipt No. R000002758
Scientific Title Acupuncture for Glaucoma
Date of disclosure of the study information 2009/10/27
Last modified on 2013/06/24

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Basic information
Public title Acupuncture for Glaucoma
Acronym Acupuncture for Glaucoma
Scientific Title Acupuncture for Glaucoma
Scientific Title:Acronym Acupuncture for Glaucoma
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness and mechanism of lowering intra ocular pressure in patient with glaucoma by acupuncture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra ocular pressure
blood flow volume of eyeball
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 standard treatment
Interventions/Control_2 standard treatment + acupuncture
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 patient with glaucoma treated for at least one year with ocular hypotensive medication
Key exclusion criteria laser trabeculoplasty, any ocular surgery
inflammation within one year
other abnormal ocular condition
starting or adjusting the use
starting or adjusting the use of any systemic medication affecting IOP within three months
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Seki
Organization Tohoku University Graduate School of Medicine
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University Graduate School of Medicine
Division name Center for Asian Traditional Medicine
Zip code
Address
TEL
Homepage URL
Email t-seki@m.tains.tohoku.ac.jp

Sponsor
Institute Center for Asian Traditional Medicine
Institute
Department

Funding Source
Organization ohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2009 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2009 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 27 Day
Last modified on
2013 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002758

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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