Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2014-12-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture and moxibustion
* therapeutic lifestyle change
* Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral)
* Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
* Group I and II will change alternatively every other week .
* Once per day five days per week.
acupuncture and moxibustion
Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
Therapeutic Lifestyle Change
* Reduced intakes of saturated fats (\<7% of total calories) and cholesterol (\<200 mg per day)
* Therapeutic options for enhancing LDL lowering
* Weight reduction
* Increased physical activity
Simvastatin
* therapeutic lifestyle change
* simvastatin
* oral administration with 10mg per day
* seven days per week for 12 weeks.
Simvastatin
10mg/d,p.o,12 weeks.
Therapeutic Lifestyle Change
* Reduced intakes of saturated fats (\<7% of total calories) and cholesterol (\<200 mg per day)
* Therapeutic options for enhancing LDL lowering
* Weight reduction
* Increased physical activity
waiting list
\- therapeutic lifestyle change
Therapeutic Lifestyle Change
* Reduced intakes of saturated fats (\<7% of total calories) and cholesterol (\<200 mg per day)
* Therapeutic options for enhancing LDL lowering
* Weight reduction
* Increased physical activity
Interventions
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acupuncture and moxibustion
Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
Simvastatin
10mg/d,p.o,12 weeks.
Therapeutic Lifestyle Change
* Reduced intakes of saturated fats (\<7% of total calories) and cholesterol (\<200 mg per day)
* Therapeutic options for enhancing LDL lowering
* Weight reduction
* Increased physical activity
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥18 to ≤75 years of age
* Fasting TG ≤400 mg/dL
* Fasting LDL-C as determined by central laboratory on admission and meeting the following LDL-C values based on risk factor status:
* 0-1 Risk Factor Group: LDL-C ≥160 mg/dL
* 2+ Risk Factor Group: LDL-C ≥130 mg/dL
* CHD or CHD risk equivalents: LDL-C ≥100 mg/dL
* Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C \<40 mg/dL);（4）Family history of premature CHD (CHD in male first degree relative \<55 years; CHD in female first degree relative \<65 years);（5）Age (men ≥45 years; women ≥55 years)
* CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk for CHD \>20%
Exclusion Criteria
* NYHA II, III or IV heart failure, or last known left ventricular ejection fraction \<30%
* Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Planned cardiac surgery or revascularization
* Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes
* Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) \>160 mmHg or diastolic BP (DBP) \>100 mmHg
* Subjects taken red yeast rice, niacin \>200 mg/d, or omega-3 fatty acids \>1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C screening
* Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to LDL-C screening
* Hyperthyroidism or hypothyroidism
* Moderate to severe renal dysfunction
* Active liver disease or hepatic dysfunction
* CK \>3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart
* Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
* Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
* Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor
* Currently enrolled in another investigational device or drug study
* Female subject during pregnant or breast feeding period
* History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
* Known sensitivity to any of the products to be administered during dosing
* Subjects couldn't provide the written informed consent and/or comply with all required study procedures
20 Years
75 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
State Administration of Traditional Chinese Medicine of the People's Republic of China
OTHER_GOV
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Xiaorong Chang, Prof.
Role: STUDY_CHAIR
Hunan University of Chinese Medicine
Locations
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Changsha Hospital of Chinese Medicine
Changsha, Hunan, China
Second Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yue ZH, He XQ, Chang XR, Yuan JL, Yu BS, Liu M, Fu L, Zhang L, Shang LC. The effect of herb-partition moxibustion on Toll-like receptor 4 in rabbit aorta during atherosclerosis. J Acupunct Meridian Stud. 2012 Apr;5(2):72-9. doi: 10.1016/j.jams.2012.01.005. Epub 2012 Feb 10.
Yue ZH, Yan J, Chang XR, Lin YP, Yi SX, Cao XP, Shen J. [Effects of cake-separated moxibustion on ultrastructures of endothelial cells of aorta in the rabbit of hyperlipemia]. Zhongguo Zhen Jiu. 2005 Jan;25(1):64-7. Chinese.
Xiaorong C, Jie Y, Zenghui Y, Jing S, Yaping L, Shouxiang Y, Xiangping C. Effects of medicinal cake-separated moxibustion on plasma 6-keto-PGF1alpha and TXB2 contents in the rabbit of hyperlipemia. J Tradit Chin Med. 2005 Jun;25(2):145-7.
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
Yan X, Chen H, Gao W, Li J, Yang X, Ye P, Zhang S, Zhao D, Zhu J, Huo Y. [Consensus standpoints from expert panel of Chinese Society of Cardiology on AHA/ACC 2013 guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults]. Zhonghua Xin Xue Guan Bing Za Zhi. 2014 Apr;42(4):275-6. No abstract available. Chinese.
Liu M, Zhang Q, Jiang S, Liu M, Zhang G, Yue Z, Chen Q, Zhou J, Zou Y, Li D, Ma M, Dai G, Zhong H, Wang Z, Chang X. Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial. Trials. 2017 Jul 10;18(1):310. doi: 10.1186/s13063-017-2029-x.
Other Identifiers
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LML
Identifier Type: -
Identifier Source: org_study_id
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