Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
DRUGEschscholtzia Californica
DRUGEschscholtzia Californica Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Patient with a Restless Leg Syndrome * Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial * Breast feeding or pregnant female, or female with no efficient contraception method * Patient with non-stabilised thyroid dysfunction * Patient with a known allergy to Eschscholtzia Californica or its compounds * Patient with alcohol or drug dependency * Patient drinking tea, coffee or Coca-Cola after 4 p.m.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sleep latency | Days 0, 7, 14 and 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 sleep duration | Days 0, 7, 14 and 28 |
| Change from baseline in Clinical Global Impression (CGI) score | Days 0, 7, 14 and 28 |
| Change from baseline in quality of life (QL questionnaire SF-23) | Days 0, 7, 14 and 28 |
| Number of patients with adverse events | up to 28 days |
| Change from baseline in morning concentration ability | Days 0, 7, 14 and 28 |
Outcome results
None listed