Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT01580358
Status:
UNKNOWN
Last Update Posted:
2012-06-21
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-02-25', 'releaseDate': '2020-02-13'}], 'estimatedResultsFirstSubmitDate': '2020-02-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in EORTC QOL-C30 at four weeks', 'timeFrame': 'baseline and four weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in BUN, Creatinine, GOT, GPT at four weeks', 'timeFrame': 'baseline and four weeks', 'description': 'monitor the liver function and renal function'}, {'measure': 'Change from baseline in Heart rate variability at four weeks', 'timeFrame': 'baseline and four weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'radiotherapy', 'chemotherapy', 'Traditional Chinese Medicine', 'Safety'], 'conditions': ['Cancer Patients Undergoing Chemotherapy or Radiotherapy']}, 'referencesModule': {'references': [{'pmid': '23206440', 'type': 'DERIVED', 'citation': 'Lo LC, Chen CY, Chen ST, Chen HC, Lee TC, Chang CS. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2012 Dec 3;13:232. doi: 10.1186/1745-6215-13-232.'}]}, 'descriptionModule': {'briefSummary': 'Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.', 'detailedDescription': 'Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy\n* age above 18 years old\n* signed informed consent\n* ability to read Chinese, ability for oral intake.\n\nExclusion Criteria:\n\n* being pregnancy\n* on breast feeding\n* completed chemotherapy or radiotherapy\n* brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four\n* delusion or hallucination\n* acute infection\n* received medications for other clinical trials.'}, 'identificationModule': {'nctId': 'NCT01580358', 'briefTitle': 'Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Changhua Christian Hospital', 'orgStudyIdInfo': {'id': 'CCMP98 -CT-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shen-Mai San', 'description': 'Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).', 'interventionNames': ['Drug: Shen-Mai San']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'starch', 'description': 'Starch in the same granule as intervention group for this double-blind trial', 'interventionNames': ['Drug: Starch']}], 'interventions': [{'name': 'Shen-Mai San', 'type': 'DRUG', 'description': 'Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).', 'armGroupLabels': ['Shen-Mai San']}, {'name': 'Starch', 'type': 'DRUG', 'description': 'It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.', 'armGroupLabels': ['starch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia Yun Chen, MD', 'role': 'CONTACT', 'email': '137877@cch.org.tw', 'phone': '+886-47238595', 'phoneExt': '4027'}, {'name': 'Lun Chien Lo, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'centralContacts': [{'name': 'Chia Yun Chen, MD', 'role': 'CONTACT', 'email': '137877@cch.org.tw', 'phone': '+886-47238595', 'phoneExt': '4027'}], 'overallOfficials': [{'name': 'Lun Chien Lo, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhua Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Committee on Chinese Medicine and Pharmacy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chia-Yun Chen', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-13', 'type': 'RELEASE'}, {'date': '2020-02-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chia-Yun Chen, MD, Changhua Christian Hospital'}}}}