UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031048
Receipt number 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 2024/02/05 08:13:14

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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 or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name



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

https://www.shokuken.or.jp/docs/business_report_2018.pdf

Publication of results

Published


Result

URL related to results and publications

https://www.shokuken.or.jp/docs/business_report_2018.pdf

Number of participants that the trial has enrolled

10

Results

Subjects with preliminary cedar pollinosis were divided into two groups (five per group) and were asked to consume fig tea and green tea for eight weeks. The results showed that there was no significant difference in the amount of change in subjective symptoms of allergy or nasal examination findings between the groups.

Results date posted

2021 Year 02 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

mild pollen allergy

Participant flow

10 subjects were selected from 30 applicants.

Adverse events

One person who consumed green tea discontinued the study due to stomach discomfort.

Outcome measures

Nasal examination

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

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

2024 Year 02 Month 05 Day



Link to view the page

Value
https://center6.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