Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: Eschscholtzia Californica
* Drug: Eschscholtzia Californica Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eschscholtzia Californica<br> | Drug: Eschscholtzia Californica<br> <br> |
| Placebo Comparator: Eschscholtzia Californica Placebo<br> | Drug: Eschscholtzia Californica Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sleep latency |  | Days 0, 7, 14 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |