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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025534
Receipt No. 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

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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
Email 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
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029141

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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