Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 1:37 AM
Study NCT ID:
NCT02319993
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2014-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-05', 'releaseDate': '2019-11-19'}], 'estimatedResultsFirstSubmitDate': '2019-11-19'}}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2014-12-14', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Quality of Life questionnaire', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suan-Zao-Ren Tang', 'Tian-wang-bu-xin-dan', 'Traditional Chinese Medicine', 'Herbs', 'Quality of life'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan', 'detailedDescription': "Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.\n\n(First year of two-years' project)\n\nDesign:\n\nRandomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.\n\nSetting:\n\nThe Chung Shan Medical University Affiliated Hospital and the Taipei City Hospital.\n\nMethods:\n\nA total of 128 subjects 20-80 years of age with a history of insomnia at least 1 month were recruited randomly assigned to SZRT (n = 48), placebo (n =32), TWBXD (n =48) and were instructed to take 6 gm 2 times per day of SZRT, TWBXD or placebo for a period of 4 weeks. The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome parameter were the global score on the World Health Organization Quality of Life questionnaire - Taiwan brief version, drugs consumption counts, sleep diary and safety profiles by structures questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)\\> 6 points.\n* No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.\n* There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.\n* Test subjects had to really understand the nature of this study, and participants signed consent.\n\nExclusion Criteria:\n\n* Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).\n* Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (\\> 140 / 90mmHg), poorly controlled diabetes (HbA1C\\> 7%), cancer, digestive ulcers (undergoing treatment).\n* 2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.\n* If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.\n* Patients unable to read and fill out the questionnaire by themselves this study.'}, 'identificationModule': {'nctId': 'NCT02319993', 'briefTitle': 'Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial', 'orgStudyIdInfo': {'id': 'CSH-CMCTC-101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIAN WANG BU XIN DAN', 'description': 'Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"', 'interventionNames': ['Drug: TIAN WANG BU XIN DAN']}, {'type': 'EXPERIMENTAL', 'label': 'Suan Tzao Ren Tang', 'description': 'Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"', 'interventionNames': ['Drug: Suan Tzao Ren Tang']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug:1/10 TIAN WANG BU XIN DAN', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TIAN WANG BU XIN DAN', 'type': 'DRUG', 'otherNames': ['TWBXD'], 'description': 'assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.', 'armGroupLabels': ['TIAN WANG BU XIN DAN']}, {'name': 'Suan Tzao Ren Tang', 'type': 'DRUG', 'otherNames': ['STRT'], 'description': 'assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.', 'armGroupLabels': ['Suan Tzao Ren Tang']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['P'], 'description': '1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks.', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine', 'investigatorFullName': 'GCRC', 'investigatorAffiliation': 'Chung Shan Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-19', 'type': 'RELEASE'}, {'date': '2019-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cheng-Chung Wei, Professor, Chung Shan Medical University'}}}}