Acupuncture and Moxibustion for Hyperlipemia

Hyperlipidemias Clinical Trial

— AMH-RCT  

Official title:

A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02269046
• Other study ID #: LML
• Status: Not yet recruiting
• Phase: N/A
• First received: September 26, 2014
• Last updated: October 16, 2014
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2014
• Source: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: Mailan Liu, Dr.
• Phone: 86-18229792024
• Email: 445007305[@]qq.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and moxibustion compared with active control, on absolute and percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject signed the informed consent

• 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:

• CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening =99 mg/dL

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Other:
• 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)

Drug:
• Simvastatin
10mg/d,p.o,12 weeks.

Other:
• 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

Locations

Country	Name	City	State
China	Changsha Hospital of Chinese Medicine	Changsha	Hunan
China	First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	Second Hospital of Hunan University of Chinese Medicine	Changsha	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine	State Administration of Traditional Chinese Medicine of the People's Republic of China, University of British Columbia

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. — View Citation

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. — View Citation

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. Chinese. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Safety summaries will include the subject incidence of adverse events, summaries of laboratory parameters (including shift tables), vital signs, and ECGs.	12 weeks	Yes
Other	Adherence of acupuncture	Adherence to the treatment (adherence rate)will be calculated using formula: Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned	12 weeks	No
Primary	low-density lipoprotein cholesterol (LDL-C)	To evaluate the effect of 12 weeks of acupuncture compared with active control, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.	12 weeks	No
Secondary	high-density lipoprotein cholesterol (HDL-C)		12 weeks	No
Secondary	total cholesterol (TC)		12 weeks	No
Secondary	triglyceride(TG)		12 weeks	No
Secondary	the rate of subjects achieving LDL-C goal		12 weeks	No