Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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.