UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014446 |
|---|---|
| Receipt number | R000016715 |
| Scientific Title | Effect of Royal jelly supplement on Dry Eye Syndrome |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2015/07/04 09:24:23 |
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Basic information
Public title
Effect of Royal jelly supplement on Dry Eye Syndrome
Acronym
Effect of Royal jelly supplement on Dry Eye Syndrome
Scientific Title
Effect of Royal jelly supplement on Dry Eye Syndrome
Scientific Title:Acronym
Effect of Royal jelly supplement on Dry Eye Syndrome
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of royal jelly supplement on dry eye
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dry eye symptom
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Royal jelly food
Interventions/Control_2
placebo
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
people who have dry eye symptom
Key exclusion criteria
People with active eye diseases except dry eye disease
Patients who take royal jelly supplements already.
Patients with serious systemic diseases
People whom the investigator or the subinvestigators consider to be ineligible for the intervention therapy in any other reason
pregnant woman
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsuboa |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211(62402)
tsubota@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Yamada |
Organization
dry eye KT
Division name
Director
Zip code
Address
4F Rune Aoyama, 3-3-11, Kitaaoyama, Minato-ku, Tokyo, Japan
TEL
03-6830-0731
Homepage URL
yamada@dryeye-kt.com
Sponsor or person
Institute
Dry eye KT
Institute
Department
Personal name
Funding Source
Organization
Yamada Reserach grant
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
羽根木の森アイクリニック
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 08 | 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
| 2014 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 14 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016715
