Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT01264068
Status:
UNKNOWN
Last Update Posted:
2010-12-21
First Post:
2010-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-20', 'studyFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total metabolites detection using LC/MS/MS', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': '1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)', 'timeFrame': 'one month'}]}, 'conditionsModule': {'keywords': ['Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause'], 'conditions': ['Menopausal Women']}, 'descriptionModule': {'briefSummary': 'Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. Many confounding factors influence activity of Chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. In this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive生化湯.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia according to PSQI\\>6\n* Informed consent\n* Female\n* Age 40-65 years\n\nExclusion Criteria:\n\n* In 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) .\n* Spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer.\n* Take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins,etc..'}, 'identificationModule': {'nctId': 'NCT01264068', 'briefTitle': 'The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'orgStudyIdInfo': {'id': 'TCHIRB-970208-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Insomnia control'}, {'type': 'EXPERIMENTAL', 'label': 'Suan Tsao Jen Tang', 'interventionNames': ['Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San']}, {'type': 'EXPERIMENTAL', 'label': 'Jia-Wey Shiau-Yau San', 'interventionNames': ['Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San']}], 'interventions': [{'name': 'Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San', 'type': 'DRUG', 'description': 'Take medicine every day 3 times, each time 4 grams.', 'armGroupLabels': ['Jia-Wey Shiau-Yau San', 'Suan Tsao Jen Tang']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jung-Nien Lai, PHD', 'role': 'CONTACT', 'email': 'kareny@ms10.hinet.net', 'phone': '02-28353456', 'phoneExt': '6651'}, {'name': 'Chia-Hao Yeh, bachelor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yen-Hui Chen, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor, School of Pharmacy,National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Taiwan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jung-Lien Lai/Taipei City Hospital', 'oldOrganization': 'Taipei City Hospital'}}}}