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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034060
Receipt No. R000038827
Scientific Title Clinical Evaluation of the Efficacy of Carrot Juice on Perennial Allergic Rhinitis of Healthy Subjects
Date of disclosure of the study information 2018/09/10
Last modified on 2019/09/09

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Basic information
Public title Clinical Evaluation of the Efficacy of Carrot Juice on Perennial Allergic Rhinitis of Healthy Subjects
Acronym Effects of Carrot Juice on Perennial Allergic Rhinitis
Scientific Title Clinical Evaluation of the Efficacy of Carrot Juice on Perennial Allergic Rhinitis of Healthy Subjects
Scientific Title:Acronym Effects of Carrot Juice on Perennial Allergic Rhinitis
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of intervention with carrot juice on perennial allergic rhinitis of healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nasal symptom score (Record score using a 5 point scale and Japan Rhinoconjunctivitis Quality of Life Questionnaire(JRQLQ)) before and 2, 4, 6, 8 weeks after the intervention with carrot juice or placebo.
Key secondary outcomes Ocular symptom score, QOL score(JRQLQ), non-specific IgE, Allergen-specific IgE, eosinophil count in nasal discharge, White blood cell differentiation count, Serum carotenoid concentrations

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Carrot juice (200 mL/day for 8 weeks)
Interventions/Control_2 Placebo(200 mL/day for 8 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) Healthy Japanese Subjects
2) Subjects who notice themselves as they are mild/moderate perennial allergic rhinitis.
3) Subjects who have positive results on serum allergen-specific IgE against house dust or mites.
4) Subjects who are judged suitable for this study by principal investigator.
Key exclusion criteria 1) Subjects who will be treated or take medicine for perennial allergic rhinitis during this study period.
2) Subjects who planning some treatment during this study period.
3) Subjects who intake the medicines, the foods for specified health uses and/or the health foods that are concerned their influence to test results.
4) Pregnant or expected pregnant, planning pregnant during this study period and lactating women
5) Subjects who have current medical history of serious disease.
6) Subjects who have previous medical history of serious disease and be judged unsuitable for this study.
7) Subjects who take medicines such as anti-histamine and anti-allergy.
8) Subjects who cannot take test food and record diary as instructions.
9) Subjects who habitually consume higher amount of alcohol ( > 60 g alcohol/day)
10) Subjects who have non-allergic rhinitis
11) Subjects who cannot eat carrot
12) Subjects with risk of allergy regarding to this study
13) Subjects who are participating in the other clinical tests. Subjects who participated in the other clinical tests within 2-months prior to this study and/or who plan to participate in the other clinical tests.
14) Subjects who donated over 200mL blood and/or blood components within the last one month to this study.
(15) Subjects who donated over 400mL blood and/or blood components within the last three month to this study.
(16) Females who donated over 400mL blood and/or blood components within the last four month to this study.
(17) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(18) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
19) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Aizawa
Organization Kagome CO.,LTD.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name Suguru
Middle name
Last name Fujiwara
Organization CPCC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 101-0047
Address 4F Chusin Building, 3-3-5 Uchikanda C hiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute Others
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor CPCC Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiyoda paramedic clinic IRB
Address 4F Chusin Building, 3-3-5 Uchikanda C hiyoda-ku, Tokyo 101-0047, JAPAN
Tel 03-5297-5548
Email IRB@cpcc.co.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 チヨダパラメディカルケアクリニック(Tiyoda paramedic clinic)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 10 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 40
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
2018 Year 08 Month 31 Day
Date of IRB
2018 Year 08 Month 31 Day
Anticipated trial start date
2018 Year 09 Month 11 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 07 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038827

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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