A double-blind placebo-controlled trial of a Lactium and Zizyphus complex for sleep
Sanofi Australia pty ltd
170 participants
Jan 6, 2014
Interventional
Conditions
Summary
The current study is investigating the effects of supplementation with a herbal complex called LZ Complex3 on sleep quality, daytime functioning, mood and brain function. The complex contains a combination of herbal ingredients that have individually been used to improve aspects such as sleep quality, mood, and calmness. The complex also contains dietary supplements that may provide nutritional support for sleep. However, there has not been any studies to date that has looked at the combination of these ingredients together and their effect on sleep quality.
Eligibility
Inclusion Criteria8
- I01. Individuals with no significant diagnosed diseases by the judgment of the Investigator, who self-report sleeping difficulties over a 1 month prior to the screening call.
- I02. Age range 18-65 years
- I03. Body Mass Index 18-30 kg/m2
- I04. Normal vital signs
- I05. Pittsburgh Sleep Quality Index Score greater than 5.
- I06. Typical bedtime between 9 pm and 12 am.
- I07. Symptoms consistent with Primary Insomnia established at screening.
- I08. Signed written informed consent
Exclusion Criteria14
- E01. Hospital Depression and Anxiety Scale (HADS) depression score greater than 8 and/or anxiety score greater than 12 (assessed at screening)
- E02. Regular use of illicit drugs, excessive or inappropriate use of over the counter (OTC) or prescription drugs or excessive use of alcohol (assessed by the Investigator or delegate and/or reported by the potential participant)
- E03. Smoking more than 10 cigarettes a day
- E04. Consumption of stimulants: more than 10 cups of tea or coffee (or equivalent of other caffeine containing drinks), thus exceeding an intake of more than 2 litres a day and/or consumption of these drinks after 5 p.m.
- E05. Allergy to milk proteins, latex or LZ Complex 3 ingredients
- E06. Subjects with a primary sleep disorder (sleep apnoea-hypopnoea, periodic limb movement disorder, restless legs syndrome, narcolepsy, idiopathic hypersomnia, Kleine-Levin syndrome)
- E07. Use of medicinal products for sleep disorders (e.g. hypnotic agents, anxiolytics, herbal remedies, homeopathy for hypnotic purposes) in the month prior to inclusion, or exhibiting withdrawal symptoms from the use of medicinal products for sleep disorders at screening.
- E08. On-going non-pharmacological treatment of sleep disorders (e.g. cognitive behavioural therapy, relaxation therapy)
- E09. Expected sleep disturbance from external sources during the study period (such as young children or other household disturbance).
- E10. Previous failure on prescription sleep medication
- E11. Pregnancy or lactation
- E12. Current sleep disturbance due to pain or a general medical condition including but not limited to Pain, Cystitis, Urinary frequency, Heart burn or others by the judgment of the Investigator would preclude participation in the study.
- E13. Sleep Efficiency greater than 85% AND Sleep Onset Latency below 31 minutes AND Wake after Sleep Onset below 31 minutes (assessed during week 1 using the Consensus Sleep Diary).
- E14. Participants who withdraw consent during screening (participants who are not willing to continue or fail to return).
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Interventions
Lactium and Zizyphus complex, LZ Complex3 a herb and supplement complex, 2 tablets (1600mg/tab) daily before retiring for sleep, for 14 days. Drug tablet return; Daily completion of participant diary; compliance check at clinic visits.
Locations(1)
View Full Details on ANZCTR
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ACTRN12613001363774