UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025534 |
|---|---|
| Receipt number | R000029141 |
| Scientific Title | Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure |
| Date of disclosure of the study information | 2017/01/30 |
| Last modified on | 2017/10/18 12:49:32 |
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Basic information
Public title
Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Acronym
Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Scientific Title
Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Scientific Title:Acronym
Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of a test food for reduction of intraocular pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Value and rate changes of intraocular pressure (Screening vs Week 12)
Key secondary outcomes
*Secondary outcomes
Value and rate changes of intraocular pressure (Screening vs Week 4; Screening vs Week 8)
*Safety
[1]Doctor's questions
[2]Blood pressure, pulsation
[3]Weight, body fat percentage, BMI
[4]Blood test (adiponectin)
[5]Blood biochemical test
[6]Urine analysis
*Other outcomes
Subject's diary(From the first day of ingestion of a test material to the last day of the test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Oral intake of the test food (1 pill in a day; 12 weeks)
Interventions/Control_2
Oral intake of the placebo food (1 pill in a day; 12 weeks)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Males and Females aged 20-74 years
[2]Individuals whose intraocular pressure is over 20mmHg at Week 0
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination in a designated day
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals having glaucomatous optic disc disorder.
[2]Individuals with serious disease.
[3]Individuals with eye disease which has influence to intraocular pressure and measurement of ocular tension (ex. inflammatory disease, corneal disease).
[4]Individuals who used a drug having influence to intraocular pressure in the past 4 weeks.
[5]Individuals who have to wear contact lens from bedtime of the day before to the completion of the inspection at each visit.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Takeshi |
Organization
Medical Corporation Shinanokai, Shinanozaka Clinic
Division name
Director
Zip code
Address
3F Yotsuya Medhical Building, 20 Samoncho Shinjuku Tokyo 160-0017, JAPAN
TEL
03-5366-3006
hi-nezu@trcp.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Santen 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 | 01 | Month | 30 | 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
| 2016 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | 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
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029141
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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