ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001589279

Ethics application status

Approved

Date submitted

17/09/2018

Date registered

25/09/2018

Date last updated

23/09/2019

Date data sharing statement initially provided

23/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1220-5521

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insomnia

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (corn-starch)

Control group

Placebo

Outcomes

Primary outcome [1]

Insomnia severity index

Timepoint [1]

End of the 4 week treatment period

Secondary outcome [1]

Sleep-onset latency (SOL) (measured with sleep diary and verified by actigraphy wristwatch).

Timepoint [1]

End of the 4 week treatment period

Secondary outcome [2]

Pittsburgh Sleep Quality Index

Timepoint [2]

End of the 4 week treatment period

Secondary outcome [3]

Depression Anxiety Stress Scales

Timepoint [3]

End of the 4 week treatment period

Secondary outcome [4]

WHO Quality of Life Instrument (WHOQOL-BREF)

Timepoint [4]

End of the 4 week treatment period

Secondary outcome [5]

Functional Outcomes of Sleep Questionnaire

Timepoint [5]

End of the 4 week treatment period

Secondary outcome [6]

Wake time after sleep onset (WASO) (measured with sleep diary and verified by actigraphy wristwatch).

Timepoint [6]

End of the 4 week treatment period

Secondary outcome [7]

Number of awakenings during the night (measured with sleep diary and verified by actigraphy wristwatch).

Timepoint [7]

End of the 4 week treatment period

Secondary outcome [8]

Sleep efficiency (SE) (measured with sleep diary and verified by actigraphy wristwatch).

Timepoint [8]

End of the 4 week treatment period

Secondary outcome [9]

Total sleep time (TST) (measured with sleep diary and verified by actigraphy wristwatch).

Timepoint [9]

End of the 4 week treatment period

Secondary outcome [10]

Adverse events (number and type). The study medication does not have any known adverse reactions; however, if events occur they will be recorded in the research documentation as a secondary outcome. If adverse events occur they will be assessed by the research investigators. If the participants need follow up or treatment for their adverse events they will be referred back to their usual treating doctor.

Timepoint [10]

End of the 4 week treatment periods and during the wash-out period. Details about adverse events will be primarily collected during the visits to the research site at the end of the two treatment periods and the end of the wash out period. In addition, the participants can call the research team at any time to report an adverse event.

Secondary outcome [11]

Leeds Sleep Evaluation Questionnaire (safety outcome)

Timepoint [11]

End of the 4 week treatment period

Eligibility

Key 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

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes and numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

There are no previous randomised controlled trials of Ziziphus spinosa seeds alone for insomnia. Therefore a total of 12 people will be recruited based on convenience sampling. THis si a cross-over study and comparisons will be assessed from participants that have data from the end of the first treatment period and the end of the second treatment period using paired analysis. Change from baseline will also be assessed within groups. Chi-squared tests will be used to associations between categorical variables (age, gender, insomnia severity, insomnia type etc). Analysis of covariance (ANOVA) will be used for repeated measures using the General Liner Model. An intention-to-treat analysis will be applied.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/01/2019

Actual

20/02/2019

Date of last participant enrolment

Anticipated

30/09/2019

Actual

Date of last data collection

Anticipated

20/12/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3083 - Bundoora

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University SHBS Athena Swan Career Break Award

Address [1]

RMIT University
PO BOX 71
Bundoora
VIC 3083

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

RMIT University
PO BOX 71
Bundoora
VIC 3083

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Institute of Technology Human Research Ethics Committee

Ethics committee address [1]

RMIT University
PO BOX 71
Bundoora
VIC 3083

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/09/2018

Approval date [1]

09/11/2018

Ethics approval number [1]

Ethics committee name [2]

RMIT University Human Research Ethics Committee

Ethics committee address [2]

GPO Box 2476, Melbourne, Victoria 3001, Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/10/2018

Approval date [2]

09/11/2018

Ethics approval number [2]

21699

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Johannah Shergis

Address

RMIT University
PO BOX 71
Bundoora
VIC 3083

Country

Australia

Phone

+61 3 9925 6527

Fax

johannah.shergis@rmit.edu.au

Contact person for public queries

Name

Johannah Shergis

Address

RMIT University
PO BOX 71
Bundoora
VIC 3083

Country

Australia

Phone

+61 3 9925 6527

Fax

johannah.shergis@rmit.edu.au

Contact person for scientific queries

Name

Johannah Shergis

Address

RMIT University
PO BOX 71
Bundoora
VIC 3083

Country

Australia

Phone

+61 3 9925 6527

Fax

johannah.shergis@rmit.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
4340	Study protocol	johannah.shergis@rmit.edu.au
4341	Statistical analysis plan	johannah.shergis@rmit.edu.au
4342	Informed consent form	johannah.shergis@rmit.edu.au
4343	Clinical study report	johannah.shergis@rmit.edu.au
4344	Ethical approval	johannah.shergis@rmit.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Medicinal seeds Ziziphus spinosa for insomnia: A randomized, placebo-controlled, cross-over, feasibility clinical trial.	2021	https://dx.doi.org/10.1016/j.ctim.2020.102657

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically