UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002254 |
|---|---|
| Receipt number | R000002758 |
| Scientific Title | Acupuncture for Glaucoma |
| Date of disclosure of the study information | 2009/10/27 |
| Last modified on | 2013/06/24 12:07:23 |
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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
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
t-seki@m.tains.tohoku.ac.jp
Sponsor or person
Institute
Center for Asian Traditional Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002758
