Acupuncture and Moxibustion for Hyperlipemia (AMH-RCT)

October 16, 2014 updated by: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410002
        • Changsha Hospital of Chinese Medicine
        • Contact:
        • Sub-Investigator:
          • Xiong
      • Changsha, Hunan, China, 410005
        • Second Hospital of Hunan University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Weiai Liu
      • Changsha, Hunan, China, 410007
        • First Hospital of Hunan University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Feng Zhong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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)
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
ACTIVE_COMPARATOR: Simvastatin
  • therapeutic lifestyle change
  • simvastatin
  • oral administration with 10mg per day
  • seven days per week for 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
Drug: Simvastatin
10mg/d,p.o,12 weeks.
OTHER: waiting list
- therapeutic lifestyle change
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
low-density lipoprotein cholesterol (LDL-C)
Time Frame: 12 weeks
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

Secondary Outcome Measures

Outcome Measure
Time Frame
high-density lipoprotein cholesterol (HDL-C)
Time Frame: 12 weeks
12 weeks
total cholesterol (TC)
Time Frame: 12 weeks
12 weeks
triglyceride(TG)
Time Frame: 12 weeks
12 weeks
the rate of subjects achieving LDL-C goal
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 12 weeks
Safety summaries will include the subject incidence of adverse events, summaries of laboratory parameters (including shift tables), vital signs, and ECGs.
12 weeks
Adherence of acupuncture
Time Frame: 12 weeks

Adherence to the treatment (adherence rate)will be calculated using formula:

Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Collaborators

University of British Columbia
State Administration of Traditional Chinese Medicine of the People's Republic of China

Investigators

  • Study Chair: Xiaorong Chang, Prof., Hunan University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (ESTIMATE)

October 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LML

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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