UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025650
Receipt No. R000029482
Scientific Title A verification study on effects of adrenal fatigue improvement: an open-label trial
Date of disclosure of the study information 2017/01/12
Last modified on 2017/08/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A verification study on effects of adrenal fatigue improvement: an open-label trial
Acronym A verification study on effects of adrenal fatigue improvement
Scientific Title A verification study on effects of adrenal fatigue improvement: an open-label trial
Scientific Title:Acronym A verification study on effects of adrenal fatigue improvement
Region
Japan

Condition
Condition Japanese adults with healthy, insomnia, or chronic fatigue syndrome
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A study to verify of the effectiveness on circadian changes in the salivary cortisol concentration as well as improved the adrenal fatigue (included chronic fatigue and insomnia)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Saliva test
The concentration of salivary cortisol
Key secondary outcomes 1. Blood test
The concentration of serum DHEA-S (dehydroepiandrosterone sulfate), serum FT (free testosterone), and serum FT3 (free triiodothyronine)

2. Subjective symptoms
Likert scale

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 4 weeks
Test materials: AFO MD
Dose: 1 pack, twice a day
Administration: Take the morning pack in the morning and take the evening pack in the evening.
*Take the powder by mouth or the powder in a half of glass (50 mL) of water and allow the powder to dissolve completely.
*If you forget to intake the pack, take it as soon as you remember within the day.
Interventions/Control_2
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. Japanese adult men or 40-69 years old of post-menopausal women (naturally menopausal women)

2. Those who are healthy, feel sleeplessness, or feel fatigue or who were diagnosed with insomnia or chronic fatigue syndrome (excluded persons taking the medicine)

3. Those who were considered as appropriate for participation in this trial by the study responsible physician

4. Those who have a smaller area under the curve (AUC: area under the salivary cortisol concentration-time curve) between 8 a.m. and 8 p.m.
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia or hypertension

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines and/or herbal medicines

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

6. Those who are smokers

7. Those who plan to take loxoprofen (such as Loxonin) during the intervention period

8. Currently visiting hospital for diseases other than insomnia and chronic fatigue syndrome

9. Those who had participated another clinical trial for three months when you signed the informed consent form for this trial

10. Others considered as inappropriate for the study by the study responsible physician
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 R&D Department
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 Autobahn Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funder(s)

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 (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 12 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
2017 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 13 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 01 Month 12 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.