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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031048
Receipt No. R000035350
Scientific Title Effects of fig tea on allergic symptoms. Placebo-controlled, double-blind, randomized trial
Date of disclosure of the study information 2019/03/31
Last modified on 2019/08/05

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Basic information
Public title Effects of fig tea on allergic symptoms.
Placebo-controlled, double-blind, randomized trial
Acronym Anti-allergic effects of fig tea.
Scientific Title Effects of fig tea on allergic symptoms.
Placebo-controlled, double-blind, randomized trial
Scientific Title:Acronym Anti-allergic effects of fig tea.
Region
Japan

Condition
Condition Hay fever
House dust allergy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect on allergic symptoms in adults with type I allergy who continuously ingested fig tea by a placebo-controlled double-blind randomized trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Between the test food group and the control food group, difference in amount of change in allergic symptom item at each time point after test food ingestion.
Key secondary outcomes 1) Blood biochemical test (immune related items)
2) Nasal examination
3) Symptom score of nose, eyes
4) VAS Questionnaire (Symptoms of Nose, Eyes, Skin, Mental Condition)

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 Prevention
Type of intervention
Food
Interventions/Control_1 Drink 500 ml of fig tea daily for 8 weeks.
Interventions/Control_2 Drink 500 ml of green tea daily 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 Person who have symptoms of cedar pollinosis or house dust allergy.
Key exclusion criteria 1)Person who has a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, other severe disease.
2)Person who has food or medicine allergy.
3)Person who plan to use medicines due to allergic rhinitis.
4)Anemia patients.
5)Overdose of alcohol.
6)Those who are planning to become pregnant or breast-feeding during the examination period
7)Participants in other clinical trials or those planning to participate.
8)Person who the attending physician determines inappropriate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Research department
Zip code 530-0044
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL 06-6135-5200
Email info@miura-cl.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Abe
Organization Toyo institute of food technology
Division name Research department
Zip code 666-0026
Address 4-23-2, Minami-Hnayashiki, Kawanishi-shi, Hyogo, Japan
TEL 072-740-3300
Homepage URL
Email tatsuya_abe@shokuken.or.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization Toyo institute of food technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyo institute of food technology
Address 4-23-2, Minami-Hnayashiki, Kawanishi-shi, Hyogo, Japan
Tel 072-740-3300
Email masahito_kogure@shokuken.or.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 医療法人花音会みうらクリニック (大阪府)Miura Clinic, Medical Corporation Kanonkai (Osaka)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 27 Day
Date of IRB
2018 Year 01 Month 09 Day
Anticipated trial start date
2018 Year 01 Month 30 Day
Last follow-up date
2018 Year 03 Month 27 Day
Date of closure to data entry
2018 Year 03 Month 27 Day
Date trial data considered complete
2018 Year 03 Month 29 Day
Date analysis concluded
2018 Year 05 Month 21 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 29 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035350

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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