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Trial registered on ANZCTR


Registration number
ACTRN12617000351314
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
8/03/2017
Date last updated
8/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Chinese herbal medicine on sleep quality in stressed people suffering from insomnia
Scientific title
The use of Chinese herbal formulas for stress related insomnia - pilot study
Secondary ID [1] 291349 0
Nil
Universal Trial Number (UTN)
Trial acronym
HIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 302333 0
Stress 302334 0
Condition category
Condition code
Alternative and Complementary Medicine 301918 301918 0 0
Herbal remedies
Mental Health 301919 301919 0 0
Anxiety
Neurological 301920 301920 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups of participants with 5 in each will be recruited over period of 12 months to confirm the efficacy in this pilot study. A fourth group will receive sham granules.
The participants will need to take 6g of herbal/sham granules twice/day for 14 consecutive days at the participant's home. Herbal granules will be taken orally. Compliance will be recorded using a sleep diary with an intervention compliance tick box.
For the intervention arms participants will be randomised to take one of the following formulas (herbal groups):
1. Chai Hu (Radix Bupleuri), Xiang Fu (Cyperus Tuber), Bai Shao (Paeonia lactiflora Pall) , Zhi Ke (Fructus Citri Aurantii), Chuan Xiong (Ligusticum striatum), and Gan Cao (Glycyrrhiza uralensis Fisch),
2. Chai Hu (Radix Bupleuri), Bai Shao (Paeonia lactiflora Pall), Sheng Di (Radix Rehmanniae) , Du Zhong (Cortex Eucommiae), Fu Shen (Sclerotum Poriae Cocos Paradicis), Suan Zao Ren (Semen Zizyphi Spinosae), Ye Jiao Teng (Caulis Polygoni Multiflori), Dan Sheng (Radix Salviae Miltiorrhizae), Yu Jin (Radix Curcumae)
3. Ye Jiao Teng (Caulis Polygoni Multiflori) and Suan Zao Ren (Semen Zizyphi Spinosae)
Intervention code [1] 297379 0
Treatment: Other
Comparator / control treatment
The control arm will be sham herbal granules which contain only 10% of the dosage of the intervention granules and 90% starch. This is not a placebo and the 10% dosage serves to reinforce blinding of participants and believed to be a non therapeutic dosage.
Control group
Active

Outcomes
Primary outcome [1] 301350 0
Insomnia Severity Index
Timepoint [1] 301350 0
14 days from the commencement of intervention phase
Secondary outcome [1] 332387 0
Depression, Anxiety and Stress Scale (DASS 21)
Timepoint [1] 332387 0
14 days from the commencement of intervention phase
Secondary outcome [2] 332389 0
Digit Span
Timepoint [2] 332389 0
14 days from the commencement of intervention phase
Secondary outcome [3] 332390 0
Chinese Medicine Questionnaire
Timepoint [3] 332390 0
14 days from the commencement of intervention phase
Secondary outcome [4] 332391 0
Fitbit Sleep Data - Sleep duration (measured in minutes)
Timepoint [4] 332391 0
14 days from the commencement of intervention phase

Eligibility
Key inclusion criteria
Insomnia lasting longer than 2 weeks (measured by Insomnia Severity Index with a score greater than 7)
English language fluency
Self reporting stress
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a history of a psychological illness or condition that interferes with the patient's ability to understand the requirements of the study.
2. Patients with a history of a psychological illness or condition that requires continuous anti-psychotic medication.
3. Adverse reactions to or inability to digest starch in their diet.
4. Need to have gluten free diet.
5. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
6. Patients with a history of advanced heart, liver and kidney diseases that is likely to interfere with the metabolism or excretion of the test medication.
7. Patients who had received an investigational new drug within the last 2 weeks.
8. Taking other herbal supplements that may interfere with the herbs in our formulas within the last 2 weeks.
9. Regular alcohol consumption. Consuming > 1 standard drink daily (30ml of spirits, 100ml of wine, or 375ml of strength beer).
10. Need to take over-night shift or early morning shift that requires get up before 6am during the study period.
11. Circumstances or work which forces the participant which prevent them from being in bed by 23:00.
12. Need to travel out of Sydney during the study period.

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
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
2 way ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2017
Actual
Date of last participant enrolment
Anticipated
28/02/2018
Actual
Date of last data collection
Anticipated
14/03/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295823 0
University
Name [1] 295823 0
University of Technology Sydney
Country [1] 295823 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway
Ultimo
NSW 2007
Country
Australia
Secondary sponsor category [1] 294671 0
None
Name [1] 294671 0
Address [1] 294671 0
Country [1] 294671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297106 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 297106 0
15 Broadway
Ultimo
NSW 2007
Ethics committee country [1] 297106 0
Australia
Date submitted for ethics approval [1] 297106 0
05/01/2016
Approval date [1] 297106 0
01/09/2016
Ethics approval number [1] 297106 0
2015000637

Summary
Brief summary
Insomnia is a very common sleep disorder, which is defined as difficulty initiating or maintaining sleep, early awakening, and interrupted or non-restorative sleep. Additionally, there is clinically significant impairment in daytime function, including poor concentration, memory, and work efficacy. Stress is a strong predict factor and thus closely associated with the onset of chronic insomnia, and its related anxiety forms a vicious cycle to further affect sleep quality and daytime efficiency.
While 85% of the general population reports a complaint of difficulty falling and/or staying asleep, about 10% present chronic insomnia and seek medical help. The common side effects of sleeping aids or sleeping medication prescribed by the GP or provided by the pharmacist are drowsiness and headache during the day, which significantly affects daily time performance of tasks. This side effect prevents the patients from continuing such treatment, if no dependence has been developed. Abuse can happen by using such medications.
Traditional Chinese medicine (TCM) uses different theoretical system explantion and thus has a different approach to address insomnia due to stress. It is considered to be due to heat in the heart, liver and kidney, which causes restless nerves. Additional symptoms recognised by the TCM diagnosis include uneasy dreams, waking up between 1 -3am, and not feeling refreshed in the morning.
According to the herbal practice by our team members, we have developed three new herbal concoctions which aim to calm the body and nerves. The concoctions were developed based on the characteristics of the individual herbs as well as the ancient concoction recorded in the Chinese Pharmacopoeia. In addition, a TGA listed concoction for stress management will also be used, which can improve sleep quality in patients with stress. We want to know which one works most effectively to carry out a large scale clinical trial on it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72994 0
Dr Hui Chen
Address 72994 0
Faculty of Science
University of Technology Sydney
15 Broadway
Ultimo
NSW 2007
Country 72994 0
Australia
Phone 72994 0
+61295141328
Fax 72994 0
Email 72994 0
[email protected]
Contact person for public queries
Name 72995 0
Shuai Zheng
Address 72995 0
Faculty of Science
University of Technology Sydney
15 Broadway
Ultimo
NSW 2007
Country 72995 0
Australia
Phone 72995 0
+61295147854
Fax 72995 0
Email 72995 0
[email protected]
Contact person for scientific queries
Name 72996 0
Hui Chen
Address 72996 0
Faculty of Science
University of Technology Sydney
15 Broadway
Ultimo
NSW 2007
Country 72996 0
Australia
Phone 72996 0
+61295141328
Fax 72996 0
Email 72996 0
[email protected]

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