ACTRN12613001363774已完成3 期
A double-blind placebo-controlled trial of a Lactium and Zizyphus complex for sleep
Sanofi Australia pty ltd0 个研究点目标入组 170 人开始时间: 2013年12月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
相似试验
尚未招募
Unknown
Double-blind study to confirm the effect of lactic acid bacteria N1487-7 on improving liver functioHealthy subjectsJPRN-UMIN000051940Miura Clinic, Medical Corporation Kanonkai100
尚未招募
不适用
Comparison between central and external applications of multi-session interferential therapy on paiMusculoskeletal painMusculoskeletal - Other muscular and skeletal disordersPhysical Medicine / Rehabilitation - PhysiotherapyACTRN12618001930279Dr Abulkhair Beatti160
已完成
不适用
A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosisJapanese cedar pollinosisJPRN-UMIN000001657Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine, University of Yamanash32
已完成
不适用
A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2010Japanese cedar pollinosisJPRN-UMIN000003065Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine, University of Yamanashi45
已完成
不适用
A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2011Japanese cedar pollinosisJPRN-UMIN000004862Department of Otorhinolaryngoloty, Head and Neck Surgery Faculty of Medicine, University of Yamanashi36