Investigating the impact of a herbal supplement on sleep in adults with insomnia symptoms

Melrose Health0 sites40 target enrollmentJune 10, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 10, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Melrose Health

•Age between 22\-60 years.
•Score between 8 and 14 on the Insomnia Severity Index to define sub\-clinical to mild insomnia severity.
•Meet DSM\-V definition of insomnia

•Subjects diagnosed with another sleep disorder (determined by self\-report, may include OSA, restless legs syndrome, narcolepsy, etc).
•Subjects who are using sedatives or hypnotics or anti\-depressants and are unwilling or unable to discontinue use during the study.
•Subjects using hormone therapy or other treatments that may interact with the study treatment.
•Subjects with major depression or other psychopathology (such as anxiety, bipolar disorder, PTSD, schizophrenia).
•Subjects who are participating in cognitive behavioural therapy for insomnia (CBT\-I) within 4 weeks of Session 1 or who will enter CBT\-I during the study period.
•Subjects with serious illness (e.g. cardiovascular disease, diabetes) that make them unsuitable for the study.
•Subjects who are allergic to any of the treatment ingredients.
•Pregnancy, breast\-feeding or women intending to become pregnant during the course of the study.
•Currently taking other over\-the\-counter medicine for sleep or melatonin in the past month.