UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004961 |
|---|---|
| Receipt number | R000005883 |
| Scientific Title | Effects of systemic administration of black currants anthocyanins on visual field deterioration of patients with glaucoma |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2011/01/26 14:23:43 |
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Basic information
Public title
Effects of systemic administration of black currants anthocyanins on visual field deterioration of patients with glaucoma
Acronym
Effects of black currants anthocyanins on glaucomatous optic neuropathy
Scientific Title
Effects of systemic administration of black currants anthocyanins on visual field deterioration of patients with glaucoma
Scientific Title:Acronym
Effects of black currants anthocyanins on glaucomatous optic neuropathy
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of black currants antocyanins on glaucomatous optic neuropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
visual field deterioration
Key secondary outcomes
changes of ocular blood flows and intraocular pressures
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
An intervention group was administrated with 50mg anthocyanins once daily for 24 months.
Interventions/Control_2
A control group was administrated with placebo once daily for 24 months.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)clinically defined glaucoma petients.
2)MD deterioration within a recent one year was less than -0.5 dB under suitable and stable IOP levels obtained by anti-glaucoma drops.
3) MD at baseline was better than -12 dB in the better eye in Humphrey visual field 30-2 test.
4) best-corrected visual acuity of 20/30 or more in at least one eye.
5) no history of cataract surgery until one year previously.
6) no ocular diseases other than glaucoma or an early to mild senile cataract that would not influence the Humphrey visual field testing.
7) reliable performance on the Humphrey visual field testing.
8) no use of other supplements including anthocyanins.
Key exclusion criteria
Any patients did not satisfy one of above criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ohguro |
Organization
Sapporo Medical University
Division name
Department of Ophthalmology
Zip code
Address
S1 W16, chuo-ku, Sapporo, Japan
TEL
011-611-2111(3440)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisae Nakayama |
Organization
Sapporo Medical University
Division name
Department of Ophthalmology
Zip code
Address
TEL
011-611-2111(3435)
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The ministry of Education, Culture, Sports, Science and Technology
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
| 2011 | Year | 01 | Month | 26 | 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
| 2006 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 26 | Day |
Last modified on
| 2011 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005883
