Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-09 @ 7:57 PM
Study NCT ID:
NCT02183233
Status:
TERMINATED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sleep latency', 'timeFrame': 'Days 0, 7, 14 and 28'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sleep duration', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in number of awakenings', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in quality of sleep', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in presence of morning sleepiness', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in morning concentration ability', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in Clinical Global Impression (CGI) score', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Change from baseline in quality of life (QL questionnaire SF-23)', 'timeFrame': 'Days 0, 7, 14 and 28'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 28 days'}]}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female above 18 or below 65 years old\n* Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months\n* Patient who has an history of psychiatric diseases, such as:\n\n * anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be \\< 10\n * depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be \\< 10\n * mania\n * schizophrenia\n * dementia\n* Patient who has an history of neurologic diseases, such as:\n\n * Parkinson syndrome\n * crania cerebral trauma post syndrome\n * brain tumor\n * fibromyalgia\n* Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic\n* Patient with an hypersomnia or a sleep apnea syndrome\n* Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea\n* Patient with a Restless Leg Syndrome\n* 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\n* Breast feeding or pregnant female, or female with no efficient contraception method\n* Patient with non-stabilised thyroid dysfunction\n* Patient with a known allergy to Eschscholtzia Californica or its compounds\n* Patient with alcohol or drug dependency\n* Patient drinking tea, coffee or Coca-Cola after 4 p.m.'}, 'identificationModule': {'nctId': 'NCT02183233', 'briefTitle': 'Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '1120.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eschscholtzia Californica', 'interventionNames': ['Drug: Eschscholtzia Californica']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Eschscholtzia Californica Placebo', 'interventionNames': ['Drug: Eschscholtzia Californica Placebo']}], 'interventions': [{'name': 'Eschscholtzia Californica', 'type': 'DRUG', 'armGroupLabels': ['Eschscholtzia Californica']}, {'name': 'Eschscholtzia Californica Placebo', 'type': 'DRUG', 'armGroupLabels': ['Eschscholtzia Californica Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}