UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060602 |
|---|---|
| Receipt number | R000069319 |
| Scientific Title | A systematic review of the efficacy of "delphinidin 3,5-diglucoside" on dry eyes effect in healthy adults. (update version) |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 15:24:02 |
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Basic information
Public title
A systematic review of the efficacy of "delphinidin 3,5-diglucoside" on dry eyes effect in healthy adults. (update version)
Acronym
A systematic review of the efficacy of "delphinidin 3,5-diglucoside" on dry eyes effect in healthy adults. (update version)
Scientific Title
A systematic review of the efficacy of "delphinidin 3,5-diglucoside" on dry eyes effect in healthy adults. (update version)
Scientific Title:Acronym
A systematic review of the efficacy of "delphinidin 3,5-diglucoside" on dry eyes effect in healthy adults. (update version)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the functional effects of delphinidin 3,5-diglucoside intake on dry eyes effect in healthy adults, including reports of the latest clinical research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Tear secretion (Schirmer's test)
Key secondary outcomes
Subjective symptoms (VAS, DEQS), Other eye-related indicators (pupillary response, tear break-up time, Flicker test)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
P-Participant: Participant
The subjects were healthy adults (those who are not suffering from any diseases, excluding those under 18 years old, pregnant women, and lactating women)
I-intervention: Intervention (food) characteristics
Continuous intake of delphinidin 3,5-diglucoside, Unlimited dosage forms, period and follow-up period.
C-Comparison: Comparison
Placebo (The placebo's formulation is not specified)
O-Outcome: Outcome
The primary outcome: Tear secretion (Schirmer's test)
The secondary outcome: Subjective symptoms (VAS, DEQS), Other eye-related indicators (pupillary response, tear break-up time, Flicker test)
S-Study design: Study design
Randomized parallel group controlled trials, randomized crossover trials, quasi-randomized parallel group controlled trials, quasi-randomized crossover trials, non-randomized parallel group controlled trials, non-randomized crossover trials or open trial
Key exclusion criteria
The literature which does not meet PICOS, such as conference abstracts (conference proceedings) that are not original articles will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Shimizu |
Organization
Oryza Oil and Fat Chemical Co., Ltd.
Division name
New Products Development Dept. R&D Center
Zip code
493-8001
Address
1 Aza Numata Kitagata, Kitagata-cho, Ichinomiya-city, Aichi-pref.
TEL
0586-86-5141
kaihatsu@mri.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Hirano |
Organization
Oryza Oil and Fat Chemical Co., Ltd.
Division name
Planning & Solution Development Department Section
Zip code
493-8001
Address
1 Aza Numata Kitagata, Kitagata-cho, Ichinomiya-city, Aichi-pref.
TEL
0586-86-5141
Homepage URL
kaihatsu@mri.biglobe.ne.jp
Sponsor or person
Institute
Oryza Oil and Fat Chemical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil and Fat Chemical 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
Not applicable
Address
Not applicable
Tel
0586-86-5141
kaihatsu@mri.boglobe.ne.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
| 2026 | Year | 02 | 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
| 2026 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Literature search]
Search across 8 databases, and search across Foods with Functional Claims search site (Consumer Affairs Agency), related papers as a hand search. The search will be conducted by reviewer A.
[Literature selection and data extraction]
Reviewer A and B will independently screen the literature and extract data based on the eligibility criteria.
[Bias risk assessment]
Evaluation selection bias (randomization, allocation concealment), blinding bias (participants, outcome assessors), attrition bias (ITT/FAS/PPS, incomplete outcome data), selective outcome reporting, other bias, summary and non-directness of individual studies. Assess the risk as "high", "medium/suspected", or "low".
[Certainty Assessment]
Evaluate the risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) for each outcome. These evaluations will be combined to assess the overall certainty of the evidence. The risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) will be assessed in three levels: "high", "medium/suspected", and "low". Certainty will be graded in four levels: A (strong), B (moderate), C (weak), D (very weak).
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069319
