Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 10:34 AM
Study NCT ID:
NCT01686451
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2012-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C496822', 'term': 'xuezhikang'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiftang@126.com', 'phone': '+8615968766021', 'title': 'Dr. JiFei Tang', 'organization': 'Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou, 325000, China'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'XueZhiKang', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Treatment Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'title': 'TG level at baseline and week 4', 'categories': [{'measurements': [{'value': '1.76', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '1.36', 'spread': '0.69', 'groupId': 'OG003'}]}]}, {'title': 'TC level at baseline and week 4', 'categories': [{'measurements': [{'value': '5.91', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '5.82', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '4.72', 'spread': '1.16', 'groupId': 'OG003'}]}]}, {'title': 'HDL level at baseline and week 4', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '0.44', 'groupId': 'OG003'}]}]}, {'title': 'LDL level at baseline and week 4', 'categories': [{'measurements': [{'value': '3.72', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '3.74', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '2.45', 'spread': '0.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison Between XueZhiKang and Simvastatin on Fatigue Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.58', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '21.58', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '19.26', 'spread': '1.85', 'groupId': 'OG002'}, {'value': '19.33', 'spread': '1.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and week 4', 'description': 'At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of XueZhiKang With Simvastatin of Physical Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'title': 'Low level at baseline and week 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Moderate level at baseline and week 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'High level at baseline and week 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at baseline and week 4', 'description': 'At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'title': 'ALT level at baseline and week 4', 'categories': [{'measurements': [{'value': '28.58', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '28.73', 'spread': '13.10', 'groupId': 'OG001'}, {'value': '30.33', 'spread': '13.30', 'groupId': 'OG002'}, {'value': '28.67', 'spread': '14.73', 'groupId': 'OG003'}]}]}, {'title': 'AST level at baseline and week 4', 'categories': [{'measurements': [{'value': '24.12', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '24.42', 'spread': '6.89', 'groupId': 'OG001'}, {'value': '25.63', 'spread': '7.53', 'groupId': 'OG002'}, {'value': '25.85', 'spread': '7.24', 'groupId': 'OG003'}]}]}, {'title': 'CPK level at baseline and week 4', 'categories': [{'measurements': [{'value': '80.82', 'spread': '24.91', 'groupId': 'OG000'}, {'value': '82.76', 'spread': '33.80', 'groupId': 'OG001'}, {'value': '91.65', 'spread': '23.71', 'groupId': 'OG002'}, {'value': '90.92', 'spread': '24.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.57', 'spread': '14.44', 'groupId': 'OG000'}, {'value': '71.95', 'spread': '14.34', 'groupId': 'OG001'}, {'value': '75.59', 'spread': '17.20', 'groupId': 'OG002'}, {'value': '76.51', 'spread': '16.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin/Baseline', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Simvastatin/Week 4', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'OG002', 'title': 'XueZhiKang/Baseline', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'OG003', 'title': 'XueZhiKang/Week 4', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}, {'value': '3024', 'groupId': 'OG002'}, {'value': '3024', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at baseline and week 4', 'description': 'We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.', 'unitOfMeasure': 'number of pills', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'FG001', 'title': 'XueZhiKang', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From August 10, 2012, through September 15, 2013, 243 patients were screened and 60 patients who met the inclusion criteria were enrolled and randomly assigned to either simvastatin (33 patients) or xuezhikang (27 patients) at medical clinic.', 'preAssignmentDetails': '183 eligible patients were excluded with 160 patients declined to participate while 19 patients were currently using lipid-lowering medications, 3 patients were suffering from chronic kidney disease or active liver disease and 1 was of currently childbearing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simvastatin', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.\n\nsimvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.'}, {'id': 'BG001', 'title': 'XueZhiKang', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.\n\nXueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.18', 'spread': '7.00', 'groupId': 'BG000'}, {'value': '47.04', 'spread': '5.83', 'groupId': 'BG001'}, {'value': '46.57', 'spread': '6.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current cigarette smoker, Categorical', 'classes': [{'title': 'Current cigarette smoker', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Not Current cigarette smoker', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Arterial hypertension, Categorical', 'classes': [{'title': 'Arterial hypertension', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Not Arterial hypertension', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Arterial blood pressure, Continuous', 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '148.06', 'spread': '18.51', 'groupId': 'BG000'}, {'value': '147.89', 'spread': '17.03', 'groupId': 'BG001'}, {'value': '147.98', 'spread': '17.71', 'groupId': 'BG002'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '84.18', 'spread': '6.95', 'groupId': 'BG000'}, {'value': '83.00', 'spread': '8.82', 'groupId': 'BG001'}, {'value': '83.65', 'spread': '7.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting blood glucose, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.10', 'spread': '0.36', 'groupId': 'BG000'}, {'value': '5.33', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '5.20', 'spread': '0.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglyceride, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '1.00', 'groupId': 'BG000'}, {'value': '1.61', 'spread': '0.65', 'groupId': 'BG001'}, {'value': '1.69', 'spread': '0.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.91', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '5.82', 'spread': '0.73', 'groupId': 'BG001'}, {'value': '5.87', 'spread': '0.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein-cholesterol, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.25', 'groupId': 'BG000'}, {'value': '1.23', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '1.26', 'spread': '0.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein-cholesterol, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '3.74', 'spread': '0.55', 'groupId': 'BG001'}, {'value': '3.73', 'spread': '0.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine aminotransferase, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.58', 'spread': '10.55', 'groupId': 'BG000'}, {'value': '30.33', 'spread': '13.30', 'groupId': 'BG001'}, {'value': '29.37', 'spread': '11.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate aminotransferase, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.12', 'spread': '7.00', 'groupId': 'BG000'}, {'value': '25.63', 'spread': '7.53', 'groupId': 'BG001'}, {'value': '24.80', 'spread': '7.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatine phosphate kinase, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.82', 'spread': '24.91', 'groupId': 'BG000'}, {'value': '91.65', 'spread': '23.71', 'groupId': 'BG001'}, {'value': '85.69', 'spread': '24.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.57', 'spread': '14.44', 'groupId': 'BG000'}, {'value': '75.59', 'spread': '17.20', 'groupId': 'BG001'}, {'value': '73.93', 'spread': '15.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fatigue score, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.58', 'spread': '2.55', 'groupId': 'BG000'}, {'value': '19.26', 'spread': '1.85', 'groupId': 'BG001'}, {'value': '19.43', 'spread': '2.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physical activity level, Categorical', 'classes': [{'title': 'Low level', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Moderate level', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'High level', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'We estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 60 patients with dyslipidemia and moderate to low cardiovascular disease (CVD) risk were randomly assigned in an open label fashion to receive either simvastatin (n=33) 20 mg daily or xuezhikang (n=27) 600 mg twice daily. All 60 patients were included in baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-20', 'studyFirstSubmitDate': '2012-09-03', 'resultsFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-20', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of XueZhiKang With Simvastatin of Physical Activity Level', 'timeFrame': 'Measured at baseline and week 4', 'description': 'At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.'}, {'measure': 'Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.'}, {'measure': 'Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.'}, {'measure': 'Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group', 'timeFrame': 'Measured at baseline and week 4', 'description': 'We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.'}], 'primaryOutcomes': [{'measure': 'Comparison Between XueZhiKang and Simvastatin on Fatigue Scores', 'timeFrame': 'Measured at baseline and week 4', 'description': 'At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.'}], 'secondaryOutcomes': [{'measure': 'Treatment Efficacy', 'timeFrame': 'Measured at baseline and week 4', 'description': 'Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '28521773', 'type': 'DERIVED', 'citation': 'Xue Y, Tao L, Wu S, Wang G, Qian L, Li J, Liao L, Tang J, Ji K. Red yeast rice induces less muscle fatigue symptom than simvastatin in dyslipidemic patients: a single center randomized pilot trial. BMC Cardiovasc Disord. 2017 May 18;17(1):127. doi: 10.1186/s12872-017-0560-z.'}]}, 'descriptionModule': {'briefSummary': 'Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD). Several studies, including one randomized, double-blind, placebo-controlled clinical trial, have suggested that the use of statins is more frequently associated with fatigue. And XueZhiKang may be not. The purpose of this study is to compare the effect of these two medications on fatigue in persons who are at moderate to low CVD risk based on the risk estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis Society) guidelines (2011) for the management of dyslipidemias.', 'detailedDescription': 'Individuals at risk for cardiovascular disease (CVD) are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these individuals have a lower incidence of coronary artery disease, ischemic stroke, and peripheral arterial disease and so on. While statins are effective at lowering cholesterol levels, their effect on fatigue is obvious and has been suggested by several studies, including one randomized, double-blind, placebo-controlled clinical trial. And XueZhiKang may be not. The purpose of this study is to compare the effect of these two medications on fatigue in persons who are at moderate to low CVD risk based on the risk estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis Society) guidelines (2011) for the management of dyslipidemias.\n\nThis study will enroll individuals who do not currently take cholesterol-lowering medications. Participants will be randomly assigned to receive 600mg of XueZhiKang twice a day, or 20mg of simvastatin daily for 4 weeks. Study visits will occur at baseline and Week 4. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue scores and physical activity levels at baseline and week 4. Pill count will be used to assess adherence of XueZhiKang and simvastatin treatment at week 4. At week 4, medication side effects will be monitored and tests of alanine aminotransferase (ALT), aspartate aminotransaminase (AST) and creatine phosphate kinase (CPK) will be performed. At week 4, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. LDL cholesterol level between 115-190 mg/dL;\n2. Able to fast prior to blood draw;\n3. Able to comfortably read and write in Chinese;\n4. Able and willing to refrain from donating whole blood during study participation;\n5. Willing to abstain from consuming large amounts of grapefruit juice.\n\nExclusion Criteria:\n\n1. Current use of lipid-lowering medications;\n2. Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization \\[percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)\\] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);\n3. Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria);\n4. Patients with moderate to severe chronic kidney disease \\[glomerular filtration rate (GFR) \\< 60 mL/min/1.73㎡\\];\n5. Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;\n6. A calculated SCORE ≥5% for 10 year risk of fatal CVD;\n7. Cancer;\n8. HIV infected;\n9. Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);\n10. Active liver disease or unexplained persistent elevated transaminase levels；\n11. Major surgery or hospitalization in the 3 months prior to study entry;\n12. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;\n13. Female of childbearing potential;\n14. Current participation in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT01686451', 'briefTitle': 'The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Comparison Between XueZhiKang and Simvastatin on Fatigue: a Single-center, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Wenzhou'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XueZhiKang', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.', 'interventionNames': ['Drug: XueZhiKang']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.', 'interventionNames': ['Drug: simvastatin']}], 'interventions': [{'name': 'XueZhiKang', 'type': 'DRUG', 'description': 'Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.', 'armGroupLabels': ['XueZhiKang']}, {'name': 'simvastatin', 'type': 'DRUG', 'otherNames': ['shujiangzhi'], 'description': 'Participants will receive 20mg of simvastatin daily for 4 weeks.', 'armGroupLabels': ['Simvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Hispital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Jifei Tang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'JiFei Tang', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}