A double-blind placebo-controlled trial of a Lactium and Zizyphus complex for sleep

Phase 3

Completed

• Conditions: Poor quality sleep; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12613001363774
• Lead Sponsor: Sanofi Australia pty ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: To assess overall sleep quality using the Pittsburgh Sleep Quality Index (PSQI) in healthy adults experiencing sleep problems.[on days 8, 9, 11, 15, 22 and 29.]