RecruitingPhase 2ACTRN12618001589279

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


Sponsor

RMIT University

Enrollment

12 participants

Start Date

Feb 20, 2019

Study Type

Interventional

Conditions

Summary

This is a randomised, placebo controlled cross-over study to assess the efficacy and safety of Ziziphus spinosa seeds in people with insomnia compared to placebo. This study aims to determine if Ziziphus spinosa seeds can improve sleep in people with insomnia, in terms of sleep quality, quantity, and associated daytime symptoms; and to determine its safety profile for insomnia. It is expected that Ziziphus spinosa seeds will alleviate some significant symptoms of insomnia and improve sleep quality, quantity, and associated daytime symptoms.The study integrates rigorous clinical trial design and research methodology and will guide the appropriate use of Chinese herbal medicine in clinical practice.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Insomnia — difficulty falling asleep, staying asleep, or waking too early — affects a significant portion of the population and can seriously impact daytime functioning, mood, and overall health. While sleeping pills are commonly prescribed, they carry risks of dependence and side effects. This study investigates a natural alternative: Ziziphus spinosa seeds, which have been used in Chinese herbal medicine for centuries to promote sleep and calm the mind. This is a crossover trial, meaning all participants will try both the Ziziphus spinosa extract and a placebo at different times, with a washout period in between. Researchers will measure sleep quality, how long it takes to fall asleep, total sleep time, and how people feel during the day. Safety will be monitored throughout. To be eligible you need to be aged 18 to 70, have insomnia meeting the clinical definition (DSM-V criteria) with a meaningful level of severity (score of at least 10 on the Insomnia Severity Index), and meet the Chinese medicine diagnosis of 'Heart Deficiency.' People who have other sleep disorders such as sleep apnoea, who are using sedatives they are unwilling to stop, who are pregnant or breastfeeding, or who have serious organ disease are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou (Common names: Spine Date Seed or Jujube Seeds; Rhamnaceae family). Dose: 2g once daily; Duration of administration: 4 weeks; Mode of admini

Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou (Common names: Spine Date Seed or Jujube Seeds; Rhamnaceae family). Dose: 2g once daily; Duration of administration: 4 weeks; Mode of administration: oral tablet. To monitor adherence to the intervention, participants will return the unused medication and packaging to the researchers for checking and documentation. The participants will return the unused medication and packaging after the two treatment periods. This is a cross-over study and there will be a 4-week wash out period between treatments.


Locations(1)

VIC, Australia

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