A clinical trial assessing the efficacy and safety of Ziziphus spinosa seeds compared to placebo for people with insomnia

RMIT University0 sites12 target enrollmentSeptember 25, 2018

Overview

No summary available.

Registry

who.int

Start Date

September 25, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Give their written informed consent to participate.
•2\.At least 18 years of age and no older than 70 years (at Visit 1\).
•3\.Minimum cut\-off of at least 10 on the ISI to define insomnia severity.
•4\.Meet the Chinese medicine criteria for Heart Deficiency (determined by a Chinese medicine practitioner).
•5\.Meet Diagnostic and Statistical Manual of Mental Disorders (DSM\-V) definition of insomnia

•1\.Participants diagnosed with another sleep disorder (including Obstructive Sleep Apnoea \[determined by the Berlin Questionnaire], restless legs syndrome, or narcolepsy).
•2\.Participants who are using sedatives or hypnotics and are unwilling or unable to discontinue use during the study.
•3\.Participants using anti\-depressants for less than 3 months (or have been using anti\-depressants for more than 3 months but have experienced an episode of depression in the previous 3 months).
•4\.Participants with major depression or other psychopathology (such as bipolar disorder).
•5\.Participants who are participating in cognitive behavioural therapy for insomnia (CBT\-I) within 4 weeks of Visit 1 or who will enter CBT\-I during the study period.
•6\.Participants with serious illness that make them unsuitable for the study (severe heart, liver or kidney disease).
•7\.Participants who have cancer and have not been in remission for at least 5 years.
•8\.Participants with abnormal liver function tests (at Visit 1\).
•9\.Pregnancy, breast\-feeding or women intending to become pregnant during the course of the study.
•10\.Participants using Ziziphus spinosa or other herbal medicine with 4 weeks of Visit 1\.