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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042444
Receipt No. R000048452
Scientific Title Effects of consumption of the test food on sleep quality: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/13

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Basic information
Public title Effects of consumption of the test food on sleep quality
Acronym Effects of consumption of the test food on sleep quality
Scientific Title Effects of consumption of the test food on sleep quality: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Scientific Title:Acronym Effects of consumption of the test food on sleep quality
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of consumption of the test food for 12 weeks on sleep quality of healthy Japanese subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The measured value and changes from screening (Scr) of "sleepiness on rising" at 12 weeks after consumption (12w)
Key secondary outcomes 1. The measured value and changes from Scr of the following items at 12w: "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item of OSA sleep inventory MA version (OSA-MA)

2. The measured value and changes from Scr of each item of sleep test every one week after the start of test-food consumption

3. The measured values of original questionnaires (The Likert scale method) at 12w

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract
Administration: Take two tablets per day with water before going to bed.

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: Placebo tablets
Administration: Take two tablets per day with water before going to bed.

*If you forget to take the test food, take it as soon as you remember within the day.
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. Healthy Japanese adults

2. Subjects who are anxious about their sleep quality

3. Subjects who are judged as eligible to participate in the study by the principal investigator

4. Subjects who have a relatively lower average score of each item of OSA-MA at screening (before consumption)
Key exclusion criteria 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who are currently undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who are currently undergoing treatment of insomnia or sleep disorder

5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

6. Subjects who are currently taking medicines (include herbal medicines) and supplements

7. Subjects who are allergic to medications and/or the test-food-related products

8. Subjects who live with their infants less than one year old

9. Subjects who co-sleep with their children (one to six years old)

10. Subjects who live with requiring long-term care persons

11. Subjects who share the bed with more than one person

12. Subjects who work late-night shift and the life-styles are irregular

13. Subjects whose dinner time is extremely irregular

14. Subjects who have nocturia three times or more

15. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

16. Subjects who pregnant, breast-feeding, and planning to become pregnant

17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

18. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size 52

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization KIM's Korean Ginseng Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

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)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 13 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 11 Day
Date of IRB
2020 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 11 Month 13 Day
Last follow-up date
2021 Year 06 Month 12 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 11 Month 13 Day
Last modified on
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048452

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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