Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02183233
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02183233
Study Brief:
Protocol Section:
NCT02183233