Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography

Safety and efficacy of scallop-plasmalogen on patients with primary insomnia:double-blind crossover trial with Polysomnography - Safety and efficacy of scallop-plasmalogen on patients with primary insomnia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021337

Enrollment

Registered

2016-03-04

Start date

2016-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary insomnia

Interventions

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 Stage 1 Placebo administered, twice a day fo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Improvement of wake after sleep onset	—

Secondary

Measure	Time frame
Improvement of sleep efficiency and sleep latency	—

Countries

Japan

Contacts

Public ContactKyoko Tsuchihashi

BOOCS Clinic Fukuoka general affairs division

kyoko@boocsclinic.com092-283-6852

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026