UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021337 |
|---|---|
| Receipt number | R000024339 |
| Scientific Title | Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2017/09/06 09:59:36 |
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Basic information
Public title
Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography
Acronym
Safety and efficacy of scallop-plasmalogen on patients with primary insomnia
Scientific Title
Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography
Scientific Title:Acronym
Safety and efficacy of scallop-plasmalogen on patients with primary insomnia
Region
| Japan |
Condition
Condition
primary insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To polysomnographically evaluate the effects of improving sleep quality in patients with insomnia by scallop-plasmalogen intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of wake after sleep onset
Key secondary outcomes
Improvement of sleep efficiency and sleep latency
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Stage 1
Test food containing 0.5 mg scallop-plasmalogen administered, twice a day for 2 weeks
Stage 2
Placebo administered, twice a day for 2 weeks
Interventions/Control_2
Stage 1
Placebo administered, twice a day for 2 weeks
Stage 2
Test food containing 0.5 mg scallop-plasmalogen administered, twice a day for 2 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Informed consent from patients or proxies
2.Male or female patients aged 25 through 65 years with primary insomnia involving hypnagogic disorder or awakening that lasts for more than three months
3.Patients who are not taking sleeping medicine continuously or are able to stop taking one-shot-medicine within 14 days of starting examination
4.Patients judged eligible for this study by the investigator
Key exclusion criteria
1.Patients with depression, history of severe mental or physical illness, or sleep disorder other than insomnia (sleep apnea syndrome, restless legs syndrome)
2.Patients with scallop allergy
3.Patients judged ineligible for this study by the investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Saito |
Organization
BOOCS Clinic Fukuoka
Division name
Hospital director
Zip code
Address
6-18 Tenya-machi, Hakata-ku, Fukuoka
TEL
092-283-6852
saito@tkz.bbiq.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Tsuchihashi |
Organization
BOOCS Clinic Fukuoka
Division name
general affairs division
Zip code
Address
6-18 Tenya-machi, Hakata-ku, Fukuoka
TEL
092-283-6852
Homepage URL
kyoko@boocsclinic.com
Sponsor or person
Institute
BOOCS Clinic Fukuoka
Institute
Department
Personal name
Funding Source
Organization
Japanese Plasmalogen Society
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2016 | Year | 03 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
