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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048042
Receipt No. R000054759
Scientific Title Effect of intake of Long pepper extract on sleep
Date of disclosure of the study information 2022/06/24
Last modified on 2022/06/13

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Basic information
Public title Effect of intake of Long pepper extract on sleep
Acronym Effect of intake of Long pepper extract on sleep
Scientific Title Effect of intake of Long pepper extract on sleep
Scientific Title:Acronym Effect of intake of Long pepper extract on sleep
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of intake of Long pepper extract on sleep
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluation of questionnaire on sleep quality
Key secondary outcomes

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food with Long pepper extract (for 4 consecutive days) - washout period more than 3 days - Intake of placebo food (for 4 consecutive days)
Interventions/Control_2 Intake of placebo food (for 4 consecutive days) - washout period more than 3 days - Intake of test food with Long pepper extract (for 4 consecutive days)
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 males and females aged over 20 years old at the time of informed consent.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study
Key exclusion criteria 1.Subjects who are in an environment where bedtime sleep is disturbed(such as baby, child and pet.).
2. Subjects who are taking medicines and health foods related to sleep, stress, and fatigue.
3.Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day).
4. Subjects who are midnight-shift worker or shift worker.
5.Subjects who do not have a constant bedtime (more than 3hours).
6. Subjects who do not have a constant exercise habits (in terms of high intensity exercise).
7. Subjects who do not have a constant lifestyle (such as day and night reversal).
8. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases.
9.Subjects who have chronic diseases and take medicine on a daily basis.
10. Subjects who are said to snore frequently during the night, and those who are often awakened by snoring.
11.Subjects who are smoker.
12.Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators.
13.Subjects who are pregnant or breast-feeding or have the will of pregnancy during the test period.
14.Subjects who may have an allergic reaction to the test food, and subjects who may have a severe allergic reaction to other foods or medicines.
15.subjects who plan to go on a business trip (domestic or overseas) or trip (domestic or overseas) during the study period.
16. Subjects who change their sleeping environment.
17. Subjects who participate in other clinical trials, who have participated in other clinical tests within one month of obtaining consent, or who are willing to participate.
18. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name MOTOKO
Middle name
Last name TAKAOKA
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code 662-8506
Address 4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. Japan
TEL 0798-51-8668
Email takaoka@mail.kobe-c.ac.jp

Public contact
Name of contact person
1st name MOTOKO
Middle name
Last name TAKAOKA
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code 662-8506
Address 4-1 Okadayama, Nhishinomiya-shi, Hyogo. Japan
TEL 0798-51-8668
Homepage URL
Email takaoka@mail.kobe-c.ac.jp

Sponsor
Institute Kobe College
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Kobe College

IRB Contact (For public release)
Organization Kobe College
Address 1089-8 Sagata, Shin-ichi, Fukuyama, Hiroshima, Japan
Tel 0798-51-8423
Email takaoka@mail.kobe-c.ac.jp

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 神戸女学院大学

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 24 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 18 Day
Date of IRB
2022 Year 06 Month 02 Day
Anticipated trial start date
2022 Year 06 Month 23 Day
Last follow-up date
2022 Year 07 Month 30 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 06 Month 13 Day
Last modified on
2022 Year 06 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054759

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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