UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033200 |
|---|---|
| Receipt number | R000037855 |
| Scientific Title | Effects of a Food Containing Extract of bilberry/bulk of pine intake on antioxidative effect in blood of glaucoma patients. |
| Date of disclosure of the study information | 2018/10/05 |
| Last modified on | 2024/04/26 14:57:13 |
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Basic information
Public title
Effects of a Food Containing Extract of bilberry/bulk of pine intake on antioxidative effect in blood of glaucoma patients.
Acronym
Bloody antioxidative effect of bilberry/bulk of pine extracts in glaucoma patietents.
Scientific Title
Effects of a Food Containing Extract of bilberry/bulk of pine intake on antioxidative effect in blood of glaucoma patients.
Scientific Title:Acronym
Bloody antioxidative effect of bilberry/bulk of pine extracts in glaucoma patietents.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of test food on antioxidative effect in blood of glaucoma patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Value and rate changes of oxidative stress marker from pre-dosing at 4 weeks after dosing
Adverse effect
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test food (1 pill in a day, 4 weeks)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Males and Females aged 20 years over and aged under 70 years old
[2] Individuals whose written informed consent has been obtained
[3]Individuals whose both eye were prevent from glaucoma progression by treating with 1 to 3 medication, and individuals who do not need the ophthalmic surgery including glaucoma operation
[4] Individuals who want to take the test food
[5] Individuals whose intraocular pressure was higher than 15 mmHg with Goldmann applanation tonometer in at least one eye.
[6] Individuals who can measure the intraocular pressure with ICare HOME tonoometer
[7] Individuals whose measuring times of intraocular pressure with ICare HOME tonometer in pre-dosing period were greater than (days of pre-dosing period x2) times
Key exclusion criteria
[1] Individuals with serious systematic disease
[2] individuals with ocular disease which may leads the blindness except glaucoma or mild cataract
[3] Individuals with hepatic or renal failure, cardiac failure, renal failure which having influence to supplement evaluation.
[4] individuals with cigarettes smoker
[5] Individuals who continuously used a antioxidative supplement or have plan to use said supplements during the study period
[6] Individuals who are likely to change the lifestyle (long journey, change in Eating habits etc.).
[7] Individuals who is pregnant, lactating, or may possibly be pregnant.
[8] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months
[9] Individuals with allergy to test food or who may possibly be allergy to test food.
[10] Individuals who are inappropriate case judged by investigator or subinvestigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane University
Division name
Ophthalmology
Zip code
693-8501
Address
89-1, Shiochi-cho, Izumo, Shimane Prefecture
TEL
0853-20-2284
mtanito@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Takagi |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
TEL
+81-6-4802-9337
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University
Address
89-1, Shiochi-cho, Izumo, Shimane Prefecture
Tel
0853-20-2259
kenkyu@med.shimane-u.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
松江赤十字病院（島根県）/Matsue Red Cross Hospital (Shimane Pref.)
島根大学(島根県)／ Shimane University (Shimane pref.)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844666/pdf/jcbn20-50.pdf
Number of participants that the trial has enrolled
18
Results
Refer to paper
Results date posted
| 2024 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 10 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
IPD sharing Plan description
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037855
| Research Plan | |
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