UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography
Title of the study (Brief title)	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	Kazuyuki Saito
Organization	BOOCS Clinic Fukuoka
Division name	Hospital director
Address	6-18 Tenya-machi, Hakata-ku, Fukuoka
TEL	092-283-6852
Email	saito@tkz.bbiq.jp

Public contact
Name of contact person	Kyoko Tsuchihashi
Organization	BOOCS Clinic Fukuoka
Division name	general affairs division
Address	6-18 Tenya-machi, Hakata-ku, Fukuoka
TEL	092-283-6852
Homepage URL
Email	kyoko@boocsclinic.com

Sponsor
Institute	BOOCS Clinic Fukuoka
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024339