Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

NCT ID: NCT02183233

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31

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.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eschscholtzia Californica

Group Type: EXPERIMENTAL

Eschscholtzia Californica

Intervention Type: DRUG

Eschscholtzia Californica Placebo

Group Type: PLACEBO_COMPARATOR

Eschscholtzia Californica Placebo

Intervention Type: DRUG

Interventions

Eschscholtzia Californica

Intervention Type: DRUG

Eschscholtzia Californica Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1120.2

Identifier Type: -

Identifier Source: org_study_id