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.
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.
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.
Inclusion Criteria:
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:
Patient who has an history of neurologic diseases, such as:
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.