Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.
1 other identifier
interventional
49
0 countries
N/A
Brief Summary
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedJuly 8, 2014
July 1, 2014
5 months
July 4, 2014
July 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in sleep latency
Days 0, 7, 14 and 28
Secondary Outcomes (8)
Change from baseline in sleep duration
Days 0, 7, 14 and 28
Change from baseline in number of awakenings
Days 0, 7, 14 and 28
Change from baseline in quality of sleep
Days 0, 7, 14 and 28
Change from baseline in presence of morning sleepiness
Days 0, 7, 14 and 28
Change from baseline in morning concentration ability
Days 0, 7, 14 and 28
- +3 more secondary outcomes
Study Arms (2)
Eschscholtzia Californica
EXPERIMENTALEschscholtzia Californica Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female above 18 or below 65 years old
- Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
- Written informed consent
You may not qualify if:
- Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months
- Patient who has an history of psychiatric diseases, such as:
- anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be \< 10
- depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be \< 10
- mania
- schizophrenia
- dementia
- Patient who has an history of neurologic diseases, such as:
- Parkinson syndrome
- crania cerebral trauma post syndrome
- brain tumor
- fibromyalgia
- Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
- Patient with an hypersomnia or a sleep apnea syndrome
- Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 8, 2014
Study Start
January 1, 1998
Primary Completion
June 1, 1998
Last Updated
July 8, 2014
Record last verified: 2014-07