UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013349 |
|---|---|
| Receipt number | R000015571 |
| Scientific Title | Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults |
| Date of disclosure of the study information | 2014/03/07 |
| Last modified on | 2014/09/11 11:30:23 |
* 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
Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults
Acronym
Safety and efficacy of a dietary supplement on sleep disorders
Scientific Title
Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults
Scientific Title:Acronym
Safety and efficacy of a dietary supplement on sleep disorders
Region
| Japan |
Condition
Condition
sleep disorders
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several clinical trials reported effects of Bovine alpha S1-casein tryptic hydrolysate or Hemerocallis fulva on sleep disorders. The purpose of this study is to evaluate safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is evaluation of sleep quality with a portable physiological signal recorder.
Key secondary outcomes
PSQI (Pittsburgh sleep quality index) and OSA-MA(OSA sleep inventory MA version).
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
A dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva is administered for 2 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Age: more than or equal to 20 years at the time of providing informed consent
- Subjects with sleep disorders
- Individuals who have never experienced psychological and critical diseases.
- Individuals who have the ability to provide written informed consent.
Key exclusion criteria
- Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs.
- Subjects judged to be inappropriate for the study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seika Kamohara MD, PhD |
Organization
DHC Corporation
Division name
Division of Research Adviser
Zip code
Address
Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL
0354423945
kamohara-seika@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seika Kamohara MD, PhD |
Organization
DHC Corporation
Division name
Division of Research Adviser
Zip code
Address
Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL
0354423945
Homepage URL
kamohara-seika@umin.ac.jp
Sponsor or person
Institute
DHC Corporation
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suidobashi Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 07 | 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
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2014 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015571
