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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047707
Receipt No. R000054397
Scientific Title Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2022/05/10
Last modified on 2022/05/10

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Basic information
Public title Effects of consumption of the test food on sleep quality in healthy Japanese subjects
Acronym Effects of consumption of the test food on sleep quality in healthy Japanese subjects
Scientific Title Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym Effects of consumption of the test food on sleep quality in healthy Japanese subjects
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 12-week consumption of the test food on sleep quality in healthy Japanese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes "Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w)
Key secondary outcomes "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA 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
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (108 mg/tablet)
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. 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: Tablet containing ripened Korean red ginseng extract (162 mg/tablet)
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3 Duration: 12 weeks
Test food: Placebo tablet
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects who are concerned about their sleep quality

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose the average of each score in the OSA-MA are relatively low at screening (before consumption; Scr)
Key exclusion criteria Subjects

1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

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

3. who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

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

5. who are judged as depressive tendency by total score of Beck Depression Inventory-II (BDI2) at Scr

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

7. who currently taking medications (including herbal medicines) and supplements

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

9. who live with their infants less than one year old

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

11. who live with requiring long-term care persons

12. who share the bed with more than one person

13. whose sleeping time or habit is irregular due to working a late-night shift

14. whose dinner time is extremely irregular

15. who have nocturia three times or more

16. 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)}

17. who are pregnant, lactation, or planning to become pregnant

18. who suffer from COVID-19

19. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

20. who are judged as ineligible to participate in the study by the physician
Target sample size 99

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
2022 Year 05 Month 10 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
2022 Year 04 Month 20 Day
Date of IRB
2022 Year 04 Month 20 Day
Anticipated trial start date
2022 Year 04 Month 28 Day
Last follow-up date
2022 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 10 Day
Last modified on
2022 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054397

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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