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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027549
Receipt No. R000028730
Scientific Title The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
Date of disclosure of the study information 2017/09/01
Last modified on 2017/09/25

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Basic information
Public title The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
Acronym The verification study of improvements in psychological stress with intake of black tea extract supplements
Scientific Title The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
Scientific Title:Acronym The verification study of improvements in psychological stress with intake of black tea extract supplements
Region
Japan

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

Objectives
Narrative objectives1 To verify study of improvements in psychological stress with intake of extracted Japanese Uva tea supplements
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes autonomic function test
1. low frequency (LF)
2. high frequency (HF)
3. LF/HF
4.autonomic function age
subjective symptoms
1. profile of Mood States 2nd edition (POMS2) Japanese version
Key secondary outcomes 1. salivary alpha-amylase activity
2. cortisol activity

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 3 weeks
Test material: The powder of extracted Uva tea
Dose: Take 4 capsules, three times a day (1 capsule for 200 mg)
Administrative: Take 4 capsules before each meal
*If you forget to take capsules, take them as soon as you remember
Interventions/Control_2 Duration: 3 weeks
Test material: crystalline cellulose and dextrin
Dose: Take 4 capsules, three times a day (1 capsule for 200 mg)
Administrative: Take 4 capsules before each meal
*If you forget to take capsules, take them as soon as you remember
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those who feel stress in daily

2. Healthy Japanese adults

3. Those who are considered to appropriate for the study by the physician

4. Those who have relatively high difference between age of autonomic nervous function and their actual age
Key exclusion criteria 1. Medical history of a malignant tumor, heart failure or myocardial infarction

2. Those who are receiving treatment or having medical history for any of the following chronic diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or any other chronic diseases

3. Daily use of Food for Specified Health Uses and/or Foods with Functional Claims

4. Those who currently take medicines (include herbal medicines) and/or supplements

5. Those who are allergic to medicines and/or the test food related products

6. Those who have taken caffeine and have become sick

7. Those who are pregnant, breast-feeding, or are expected to become pregnant during the trial period

8. Another clinical test participant within three months before the informed consent form submission

9. Others assessed as inappropriate for this test by the doctor responsible for the test

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funder(s) 1. WASEDA University Research Organization for Nano & Life Innovation

2. Mitsui Sugar Co., Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団 盛心会 タカラクリニック
Seishin-kai Medical Association Inc, Takara Medical Clinic

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 30 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028730

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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