UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028538 |
|---|---|
| Receipt number | R000032664 |
| Scientific Title | Examination on an influence of a test food product on oxidative stress in glaucoma patients |
| Date of disclosure of the study information | 2017/08/07 |
| Last modified on | 2018/03/01 08:41:43 |
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Basic information
Public title
Examination on an influence of a test food product on oxidative stress in glaucoma patients
Acronym
Examination on an influence of a test food product on oxidative stress in glaucoma patients
Scientific Title
Examination on an influence of a test food product on oxidative stress in glaucoma patients
Scientific Title:Acronym
Examination on an influence of a test food product on oxidative stress in glaucoma patients
Region
| Japan |
Condition
Condition
Normal tension glaucoma patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an influence of a test food product on oxidative stress in normal tension glaucoma patients aged 40 and over and assigning them to take the test food product for four weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
8-OHdG
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Four-week intake of the test food product
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females with Japanese nationality aged 40 and over
2) Diagnosed with normal tension glaucoma
3) Persons who can bring their glaucoma medication on study days
4) Low in biological antioxidant potential (BAP) and high in oxidative stress (8-OHdG) in urine
Key exclusion criteria
"1) Presence of severe ophthalmic disorder and regular visit to an ophthalmic clinic
2) High myopia
3) Within three months after eye surgery
4) Previous history of the LASIK procedure
5) Presence of disorder with a possible influence on study results (cancer, high-blood pressure, diabetes, amblyopia, autoimmune disorder, dysthyroidism, etc.)
6) Intake of a food product (antioxidant supplements other than vitamin C, etc.) with a possible influence on the study results at a frequency of once a week or more within the last month, or desired to take the food product at the frequency of once a week or more
7) Previous history of drug allergy or food allergy, possible onset of allergy by the study
8) Currently in treatment with medication that regulates blood pressure or blood flow
9) Presence of disorder that requires constant medication, or previous history of severe disorder that required treatment with medication
10) Regular intake of another supplement or non-prescription drug (including ophthalmic drops for purposes other than glaucoma treatment of glaucoma)
11) Persons whose results of clinical and physical examination prior to intake of the test food product significantly deviate from reference ranges
12) Current participation in another clinical study or participation in another clinical study within the last month since acquisition of the consent
13) Pregnant or desired to become pregnant and nurse during the study period
14) Determined to be unsuitable as subjects from results of the lifestyle survey
15) Determined by the investigator to be unsuitable for enrollment in this study
"
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ochitani daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ochitani daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Wakomoto 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
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
| 2017 | Year | 08 | Month | 07 | 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
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 04 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032664
