Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT02929420
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005348', 'term': 'Fibrocystic Breast Disease'}], 'ancestors': [{'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the size of breast lumps', 'timeFrame': "after 30 days' treatment", 'description': 'Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the size of breast lumps', 'timeFrame': "after 60 days' treatment", 'description': 'Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the size of breast lumps', 'timeFrame': "after 90 days' treatment", 'description': 'Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the scope of breast lumps', 'timeFrame': "after 30 days' treatment", 'description': 'Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the scope of breast lumps', 'timeFrame': "after 60 days' treatment", 'description': 'Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the scope of breast lumps', 'timeFrame': "after 90 days' treatment", 'description': 'Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the hardness of breast lumps', 'timeFrame': "after 30 days' treatment", 'description': 'Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the hardness of breast lumps', 'timeFrame': "after 60 days' treatment", 'description': 'Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'the hardness of breast lumps', 'timeFrame': "after 90 days' treatment", 'description': 'Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.'}, {'measure': 'pain of breast', 'timeFrame': "after 30 days' treatment", 'description': 'According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.'}, {'measure': 'pain of breast', 'timeFrame': "after 60 days' treatment", 'description': 'According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.'}, {'measure': 'pain of breast', 'timeFrame': "after 90 days' treatment", 'description': 'According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.'}], 'secondaryOutcomes': [{'measure': 'all adverse reactions after taking Xiaoru Sanjie capsule', 'timeFrame': "after 30 days' treatment", 'description': 'Number of Participants with different adverse reactions after taking treatment.'}, {'measure': 'all adverse reactions after taking Xiaoru Sanjie capsule', 'timeFrame': "after 60 days' treatment", 'description': 'Number of Participants with different adverse reactions after taking treatment.'}, {'measure': 'all adverse reactions after taking Xiaoru Sanjie capsule', 'timeFrame': "after 90 days' treatment", 'description': 'Number of Participants with different adverse reactions after taking treatment.'}, {'measure': 'the level of estrogen', 'timeFrame': "after 30 days' treatment"}, {'measure': 'the level of estrogen', 'timeFrame': "after 60 days' treatment"}, {'measure': 'the level of estrogen', 'timeFrame': "after 90 days' treatment"}, {'measure': 'the level of progestin', 'timeFrame': "after 30 days' treatment"}, {'measure': 'the level of progestin', 'timeFrame': "after 60 days' treatment"}, {'measure': 'the level of progestin', 'timeFrame': "after 90 days' treatment"}, {'measure': 'the level of prolactin', 'timeFrame': "after 30 days' treatment"}, {'measure': 'the level of prolactin', 'timeFrame': "after 60 days' treatment"}, {'measure': 'the level of prolactin', 'timeFrame': "after 90 days' treatment"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multicenter', 'randomized', 'open', 'parallel controlled'], 'conditions': ['Fibrocystic Disease of Breast']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.', 'detailedDescription': 'This is a multicenter, randomized, open and parallel controlled clinical study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-65 years old female patients with cyclomastopathy who signed a written informed consent.\n* The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.\n* They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.\n* They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..\n* Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.\n* Excluding breast fibrocellular tumor, breast cancer and other breast diseases.\n* Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.\n* Be judged as over middle degree depression by the Hamilton's depression scale.\n* Allergic constitution patients, and people who are allergic to a variety of drugs.\n* Any medical history which may interfere with the test results or increase the risk of patients according to the investigators.\n* Patients who have received treatment of other diseases, and those treatment methods and targets may have an impact on the indicators of this study."}, 'identificationModule': {'nctId': 'NCT02929420', 'briefTitle': 'A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule', 'orgStudyIdInfo': {'id': 'ry-2016-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xiaoru Sanjie capsules', 'description': 'a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.', 'interventionNames': ['Drug: Xiaoru Sanjie capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Xiao Yao pills', 'description': 'a kind of traditional chinese medicine that is efficient and safe to treat hyperplasia of mammary glands.\n\nXiaoyao pills,three pills every time,three time a day,PO,last three months.', 'interventionNames': ['Drug: Xiao Yao pills']}], 'interventions': [{'name': 'Xiaoru Sanjie capsules', 'type': 'DRUG', 'otherNames': ['Xiaoru Sanjie capsule'], 'description': 'Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.', 'armGroupLabels': ['Xiaoru Sanjie capsules']}, {'name': 'Xiao Yao pills', 'type': 'DRUG', 'otherNames': ['ease pills'], 'description': 'Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.', 'armGroupLabels': ['Xiao Yao pills']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Ren, MD, PhD', 'role': 'CONTACT', 'email': 'renyyyyy@126.com', 'phone': '13700222161'}], 'facility': 'Yu Ren', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yu Ren', 'role': 'CONTACT', 'email': 'renyyyyy@126.com', 'phone': '13700222161'}], 'overallOfficials': [{'name': 'Yu Ren, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}