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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038511
Receipt No. R000043885
Scientific Title Evaluate changes in atopic symptoms due to natural mineral water intake : a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2019/11/12
Last modified on 2020/04/16

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Basic information
Public title Evaluate changes in atopic symptoms due to natural mineral water intake
Acronym Atopy trial of natural mineral water
Scientific Title Evaluate changes in atopic symptoms due to natural mineral water intake : a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym Evaluate changes in atopic symptoms due to natural mineral water intake
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate changes in inflamed areas by ingesting natural mineral water for 12 weeks for subjects with non-severe atopic symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood test,Urinalysis, VAS, visual evaluation by doctor, subjective evaluation
Key secondary outcomes

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 Ingest test article (for 12 weeks)
Interventions/Control_2 Ingest placebo (for 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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who suffer from mild atopic symptoms
2. Subjects with skin dryness and sensitive skin
Key exclusion criteria 1. Subjects who are pregnant or breastfeeding
2.Subjects who are severe or moderate in the classification of symptoms of atopic dermatitis
3. Subjects participating in other human trial
4. Subjects who are scheduled to receive treatment that affects the inflammatory site during the study period
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization Hita Tenryosui 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 Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2019 Year 11 Month 12 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 26
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
2019 Year 10 Month 21 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 11 Month 12 Day
Last follow-up date
2020 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 07 Day
Last modified on
2020 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043885

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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