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Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

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ClinicalTrials.gov Identifier: NCT02183233
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Eschscholtzia Californica Drug: Eschscholtzia Californica Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 1998
Actual Primary Completion Date : June 1998

Arm Intervention/treatment
Experimental: Eschscholtzia Californica Drug: Eschscholtzia Californica
Placebo Comparator: Eschscholtzia Californica Placebo Drug: Eschscholtzia Californica Placebo



Primary Outcome Measures :
  1. Change from baseline in sleep latency [ Time Frame: Days 0, 7, 14 and 28 ]

Secondary Outcome Measures :
  1. Change from baseline in sleep duration [ Time Frame: Days 0, 7, 14 and 28 ]
  2. Change from baseline in number of awakenings [ Time Frame: Days 0, 7, 14 and 28 ]
  3. Change from baseline in quality of sleep [ Time Frame: Days 0, 7, 14 and 28 ]
  4. Change from baseline in presence of morning sleepiness [ Time Frame: Days 0, 7, 14 and 28 ]
  5. Change from baseline in morning concentration ability [ Time Frame: Days 0, 7, 14 and 28 ]
  6. Change from baseline in Clinical Global Impression (CGI) score [ Time Frame: Days 0, 7, 14 and 28 ]
  7. Change from baseline in quality of life (QL questionnaire SF-23) [ Time Frame: Days 0, 7, 14 and 28 ]
  8. Number of patients with adverse events [ Time Frame: up to 28 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183233     History of Changes
Other Study ID Numbers: 1120.2
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders