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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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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 |
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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. |
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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. |
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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. |
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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 |
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Age-upper limit |
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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) |
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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 |
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Target sample size | 99 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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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 | |
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Research case data | |
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