HyperlipidemiasAMH-RCTNCT02269046
Acupuncture and Moxibustion for Hyperlipemia
A study testing acupuncture and moxibustion, Simvastatin and Therapeutic Lifestyle Change in people with Hyperlipidemias, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- acupuncture and moxibustion, Simvastatin and Therapeutic Lifestyle Change
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Changsha Hospital of Chinese Medicine
Changsha, Hunan, 410002
Xiong, Dr., 973920892@qq.com
Xiong
Second Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410005
Liu, 55999630@qq.com
Weiai Liu
First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410007
Wang, 1835591292@qq.com
Feng Zhong
About this study
Official title: 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.
- Conditions
- Hyperlipidemias
- Being tested
- acupuncture and moxibustion, Simvastatin, Therapeutic Lifestyle Change
- Keywords
- acupuncture, moxibustion, hyperlipidemias, effectiveness
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and moxibustionOther
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)
SimvastatinDrug
10mg/d,p.o,12 weeks.
Therapeutic Lifestyle ChangeOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and moxibustion | Experimental | * 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. Receives: Other: acupuncture and moxibustion; Other: Therapeutic Lifestyle Change |
| Simvastatin | Active comparator | * therapeutic lifestyle change
* simvastatin
* oral administration with 10mg per day
* seven days per week for 12 weeks. Receives: Drug: Simvastatin; Other: Therapeutic Lifestyle Change |
| waiting list | Other | - therapeutic lifestyle change Receives: Other: Therapeutic Lifestyle Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
high-density lipoprotein cholesterol (HDL-C)
Measured: 12 weeks
total cholesterol (TC)
Measured: 12 weeks
triglyceride(TG)
Measured: 12 weeks
the rate of subjects achieving LDL-C goal
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, State Administration of Traditional Chinese Medicine of the People's Republic of China
- Responsible party
- Sponsor
- Investigators
- Xiaorong Chang, Prof., Study chair, Hunan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269046
- Sponsor's protocol ID
- LML
- Acronym
- AMH-RCT
- Status last verified
- Aug 2014
- First submitted
- 26 Sep 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22483185Yue 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.
PubMed 16309161Xiaorong 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.
PubMed 16136949Expert 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.
PubMed 11368702Stone 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.
PubMed 24222016Yan 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.
PubMed 24924450Liu 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.
PubMed 28693531
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias
- ClinicalTrials.gov ID
- NCT02269046
- Acronym / sponsor ID
- AMH-RCT / LML
- Conditions
- Hyperlipidemias
- Keywords
- acupuncture, moxibustion, hyperlipidemias, effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- University of British Columbia, State Administration of Traditional Chinese Medicine of the People's Republic of China
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and moxibustion | Experimental | Other: acupuncture and moxibustion, Other: Therapeutic Lifestyle Change* 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. |
| Simvastatin | Active comparator | Drug: Simvastatin, Other: Therapeutic Lifestyle Change* therapeutic lifestyle change * simvastatin * oral administration with 10mg per day * seven days per week for 12 weeks. |
| waiting list | Other | Other: Therapeutic Lifestyle Change- therapeutic lifestyle change |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture and moxibustionWarm 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 | Acupuncture and moxibustion |
| Simvastatin10mg/d,p.o,12 weeks. | Drug | Simvastatin |
| 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 | Other | Acupuncture and moxibustion, Simvastatin, waiting list |
Primary outcome
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.
4 secondary outcomes
high-density lipoprotein cholesterol (HDL-C)
Time frame: 12 weeks
total cholesterol (TC)
Time frame: 12 weeks
triglyceride(TG)
Time frame: 12 weeks
the rate of subjects achieving LDL-C goal
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Background: PubMed 22483185Yue 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.
- Background: PubMed 16309161Yue 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.
- Background: PubMed 16136949Xiaorong 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.
- Background: PubMed 11368702Expert 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.
- Background: PubMed 24222016Stone 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.
- Background: PubMed 24924450Yan 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.
- Derived from this study: PubMed 28693531Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaorong Chang, Prof. study chair
Hunan University of Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and moxibustion, Simvastatin and Therapeutic Lifestyle Change in people with Hyperlipidemias, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mailan Liu, Dr. (86-18229792024, 445007305@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low-density lipoprotein cholesterol (LDL-C) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269046, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.