A clinical trial investigating the impact of a herbal supplement on sleep in individuals with insomnia symptoms

Not Applicable

• Conditions: Insomnia; Alternative and Complementary Medicine - Herbal remedies; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000733875
• Lead Sponsor: Melrose Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-10
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index score from baseline[Baseline (Day 0), Mid-study (Day 14), and 4 weeks after treatment commencement (Day 28, primary outcome) ]