UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032050 |
|---|---|
| Receipt number | R000036538 |
| Scientific Title | Oxidative stress level before and after supplement intake |
| Date of disclosure of the study information | 2018/04/06 |
| Last modified on | 2023/04/05 13:41:33 |
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Basic information
Public title
Oxidative stress level before and after supplement intake
Acronym
Supplement intake test
Scientific Title
Oxidative stress level before and after supplement intake
Scientific Title:Acronym
Supplement intake test
Region
| Japan |
Condition
Condition
glaucoma, cataract, diabetic retinopatyhy,central serus retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate oxidative stress change after supplements intake for two montshs in patients with glaucoma, cataract, diabetic retinopatyhy,central serus retinopathy.
Basic objectives2
Others
Basic objectives -Others
nothing particular
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We focus on antioxidative potential, BAP level.
Key secondary outcomes
We investigate other oxidative stress level, dROMs, 8-OHsG, AGE, pentosidine(diabetic retinopatyhy), and glutathione.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants take 2 tablets in a day for eight 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with Glaucoma, cataract, diabetic retinopathy, central serous chorioretinopathy.
(2)glaucoma stage:from -2dB to -12dB according to MD.
Diabetic retinopathy:NDR or SDR
(3)BAP:from 1600 to 2100 nmol/L
(4)dROMs: more than 300 CARR U
(5)BMI:less than 25 kg/m2
Key exclusion criteria
(1)they have other ophthalmic conditions.
(2)high myopia
(3)LASIK
(4)after surgery within three months
(5)cancer
(6)hypertension
(7)autoimmune disease, thyroid disease
(8)pill
(9)other supplements
(10)other clinical trial participants
(11)allergic to supplement of this trial
(12)pregnant woman
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Himori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi, Japan
TEL
+81227177294
n-himori@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Himori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi, Japan
TEL
022-717-7294
Homepage URL
n-himori@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakamoto company
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
Tohoku University
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
Tel
+81227177294
n-himori@oph.med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 06 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036538
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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