UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039753 |
|---|---|
| Receipt number | R000045304 |
| Scientific Title | Effects of fig tea on atopic dermatitis. Placebo-controlled, double-blind, randomized trial |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2022/10/31 17:02:00 |
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Basic information
Public title
Effects of fig tea on atopic dermatitis.
Placebo-controlled, double-blind, randomized trial
Acronym
Atopic dermatitis inhibitory effects of fig tea.
Scientific Title
Effects of fig tea on atopic dermatitis.
Placebo-controlled, double-blind, randomized trial
Scientific Title:Acronym
Atopic dermatitis inhibitory effects of fig tea.
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of fig tea on atopic dermatitis symptoms is evaluated by a placebo-controlled double-blind randomized trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in the symptoms of atopic dermatitis between the test food group and the control food group were determined by the EASI (Eczema Area and Severity Index), blood biochemical tests, POEM (Patient-Oriented Eczema Measure) at 4, 8, and 12 weeks after ingestion.
Key secondary outcomes
VAS Quetionnaire (Skin condition, Itch, Medical 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
Numbered container method
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 water 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 mild symptoms of atopic dermatitis.
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 atopic dermatitis.
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
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL
06-6135-5200
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
23-2, 4chome, Minami-Hanayashiki, Kawanishi-shi, Hyogo, Japan
TEL
072-740-3300
Homepage URL
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
Research etichs committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
Tel
06-6135-5200
mterashima@miura-cl.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）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.shokuken.or.jp/docs/business_report_2020.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.shokuken.or.jp/docs/business_report_2020.pdf
Number of participants that the trial has enrolled
30
Results
A double-blind randomized controlled trial (RCT) was conducted in patients with mild atopic dermatitis (AD). The test group received fig tea and the control group received water for 8 weeks, and the changes in AD symptoms were evaluated (15 subjects /group). The EASI score was significantly decreased by the continuous intake of fig tea compared to the water group. In addition, the fig tea group showed a significant decrease in AST (OGT) and LDH, an indicator of liver function, and a decreasing trend in ALP.
Results date posted
| 2021 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mild atopic dermatitis (EASI score:1.3-15.0)
Participant flow
30 subjects were selected from 88 candidates based on EASI score
Adverse events
N/A
Outcome measures
Physician visual assessment with atopic dermatitis (EASI score)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045304
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