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

Phase 2

Recruiting

• Conditions: Insomnia; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001589279
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity index [End of the 4 week treatment period]