UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037921 |
|---|---|
| Receipt number | R000043223 |
| Scientific Title | Clinical Evaluation of the Efficacy of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis of Healthy Subjects |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2020/03/05 09:59:15 |
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Basic information
Public title
Clinical Evaluation of the Efficacy of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis of Healthy Subjects
Acronym
Effects of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis
Scientific Title
Clinical Evaluation of the Efficacy of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis of Healthy Subjects
Scientific Title:Acronym
Effects of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of intervention with mixed vegetables and fruits 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) before and 2, 4, 6, 8 weeks after the intervention with mixed vegetables and fruits juice or placebo.
Key secondary outcomes
Nasal symptom score (Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ)), Ocular symptom score, QOL score (JRQLQ), non-specific IgE, Allergen-specific IgE, eosinophil count in nasal discharge, 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
Mixed vegetables and fruits juice (195 mL/day for 8 weeks)
Interventions/Control_2
Placebo (195 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
| 60 | 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 have positive results on serum allergen-specific IgE against Poaceae or Ambrosia artemisiifolia and are judged that symptoms of allergic rhinitis depend on their antigen.
2) Subjects who have non-allergic rhinitis
3) Subjects who have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, and deviated septum.
4) Subjects who take medicines such as anti-histamine and anti-allergy.
5) Subjects who have bronchial asthma as a complication.
6) Subjects who currently receive or have previously received allergen immunotherapy.
7) Subjects who have current medical history of serious disease in heart, liver, kidney and digestive system.
8) Subjects who have previous medical history of serious disease and be judged unsuitable for this study by principal investigator.
9) Subjects who will be treated or take medicine for perennial allergic rhinitis during this study period.
10) Subjects who have vegetables-based diet
11) Subjects who intake the medicines, the foods for specified health uses and/or the health foods that are concerned their influence to test results.
12) Pregnant or expected pregnant, planning pregnant during this study period and lactating women
13) Subjects who cannot take test food and record diary as instructions.
14) Subjects who habitually consume higher amount of alcohol (=> 60 g alcohol/day)
15) Subjects with risk of allergy regarding to this study
16) 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.
17) Subjects who donated over defined blood and/or blood components amounts before this study.
18) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Inoue |
Organization
Kagome CO.,LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Takuro_Inoue@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 Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Kagome CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Kagome CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic IRB
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel
03-5297-5548
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(東京都)/Chiyoda Paramedical Care Clinic)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 06 | 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
| 2019 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043223
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