Not Yet RecruitingPhase 2ACTRN12617000351314

The effect of Chinese herbal medicine on sleep quality in stressed people suffering from insomnia

The use of Chinese herbal formulas for stress related insomnia - pilot study

Sponsor

University of Technology Sydney

Enrollment

20 participants

Start Date

Mar 13, 2017

Study Type

Interventional

Conditions

Insomnia Stress

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

Insomnia lasting longer than 2 weeks (measured by Insomnia Severity Index with a score greater than 7)
English language fluency
Self reporting stress

Exclusion Criteria12

Patients with a history of a psychological illness or condition that interferes with the patient's ability to understand the requirements of the study.
Patients with a history of a psychological illness or condition that requires continuous anti-psychotic medication.
Adverse reactions to or inability to digest starch in their diet.
Need to have gluten free diet.
Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
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.
Patients who had received an investigational new drug within the last 2 weeks.
Taking other herbal supplements that may interfere with the herbs in our formulas within the last 2 weeks.
Regular alcohol consumption. Consuming > 1 standard drink daily (30ml of spirits, 100ml of wine, or 375ml of strength beer).
Need to take over-night shift or early morning shift that requires get up before 6am during the study period.
Circumstances or work which forces the participant which prevent them from being in bed by 23:00.
Need to travel out of Sydney during the study period.

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Interventions

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 n

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)