None listed
Conditions
Brief 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.
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.
Sponsors
Sanofi Australia pty ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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).
Outcome results
None listed