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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032050
Receipt No. R000036538
Scientific Title Oxidative stress level before and after supplement intake
Date of disclosure of the study information 2018/04/06
Last modified on 2018/04/01

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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
Middle name
Last name Noriko Himori
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1 Seiryo-cho Aoba-ku Sendai Miyagi, Japan
TEL 022-717-7294
Email n-himori@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Himori
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1 Seiryo-cho Aoba-ku Sendai Miyagi, Japan
TEL 022-717-7294
Homepage URL
Email n-himori@oph.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
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
2018 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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