Phlegm-Dampness SyndromeNCT07624604
Evaluation of the Therapeutic Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Patients With Dyslipidemia and Phlegm-Dampness Syndrome
A study testing Auricular Acupressure, Atorvastatin and Diet and exercise regimen in people with Phlegm-Dampness Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Dyslipidemia (DL) is a metabolic disorder characterized by abnormal levels of blood lipids and is an important risk factor for cardiovascular disease. Although current management primarily relies on lifestyle modification and lipid-lowering medications, particularly statins, some patients may have an inadequate… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Phlegm-Dampness Syndrome
- What is being tested?
- Auricular Acupressure, Atorvastatin and Diet and exercise regimen
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Feb 2026to 10 Jun 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Dyslipidemia (DL), untreated or discontinued treatment for at least 1 month, and not taking drugs that induce DL.
- Laboratory Criteria: LDL-c levels between 2.6 and 4.9 mmol/L.
- TCM Criteria:
- Diagnosed with Phlegm-Dampness syndrome in patients with DL according to the "Guiding Principles for Clinical Research on Combined Traditional Chinese and Western Medicine":
- Primary symptoms: Obesity, heavy sensation in the head, chest tightness, nausea/phlegm expectoration, numbness in limbs.
- Secondary symptoms: Palpitations, insomnia, bland taste in the mouth, poor appetite.
- Tongue manifestations: Enlarged/flabby tongue, greasy/slippery tongue coating. Pulse: String-taut and slippery pulse (Wiry-Slippery pulse). Diagnostic threshold: Confirmed when presenting >= 50% of TCM Phlegm-Dampness syndrome symptoms in patients with DL.
Who cannot join
- Participants are non-compliant with the treatment protocol.
- Participants decline to continue study participation for any reason (Withdrawal of consent).
- Participants experience health events during the study and do not wish to continue participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Managing Blood Lipid Levels and Improving Phlegm-Dampness Symptoms in 80 Patients With Dyslipidemia and Phlegm-Dampness Syndrome: A Randomized Controlled Trial
Dyslipidemia (DL) is a metabolic disorder characterized by abnormal levels of blood lipids and is an important risk factor for cardiovascular disease. Although current management primarily relies on lifestyle modification and lipid-lowering medications, particularly statins, some patients may have an inadequate treatment response, experience adverse effects, or have difficulty maintaining long-term adherence.
Traditional Chinese Medicine therapies are increasingly used as complementary approaches to conventional treatment. Auricular acupuncture, which stimulates specific acupoints on the ear, has been investigated for its potential effects on lipid metabolism. In Traditional Chinese Medicine, Phlegm-Dampness syndrome is considered a common syndrome pattern associated with dyslipidemia. However, clinical evidence regarding the effects of auricular acupuncture on blood lipid parameters and Phlegm-Dampness symptoms in patients with dyslipidemia remains limited, particularly in Vietnam.
This randomized controlled trial evaluates the effects of auricular acupuncture combined with atorvastatin compared with atorvastatin plus sham auricular acupuncture in patients with dyslipidemia presenting with Phlegm-Dampness syndrome. The primary outcome is the change in blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), from baseline to the end of the 8-week intervention. Changes in clinical symptoms of Phlegm-Dampness syndrome are also evaluated.
Read the detailed description
This single-blind, randomized, sham-controlled clinical trial includes 80 outpatients aged 18 years or older with dyslipidemia presenting with Phlegm-Dampness syndrome at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. Only participants are blinded to group allocation. Participants are randomly assigned to two equal groups. Both groups receive atorvastatin 20 mg once daily after dinner and are advised to follow a lipid-lowering, high-fiber diet.
The intervention group receives Khanh Phong intradermal auricular needles applied to five auricular acupoints: Pi (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6a), and Shenmen (TF4). The therapeutic points are selected according to traditional medicine treatment principles for Phlegm-Dampness syndrome and the Vietnamese traditional medicine guideline. Participants are instructed to perform self-acupressure four times daily. The control group receives sham auricular acupuncture performed by inserting the same type of intradermal auricular needles used in the intervention group at three predefined auricular points considered theoretically unrelated to the treatment of dyslipidemia and Phlegm-Dampness syndrome: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4). Participants in the control group are not instructed to perform self-acupressure.
The intervention period lasts 8 weeks. In both groups, intradermal auricular needles are applied at the initial treatment session and subsequently replaced every 5 days, for a total of 12 treatment sessions. In the intervention group, the treated ear is alternated between sessions; in the control group, the needles are applied to the left ear. Participants are monitored for 15 minutes after each procedure and are instructed regarding monitoring for potential adverse events, including fainting, localized pain or swelling, ear bleeding, infection, and perichondritis.
Blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), are measured at baseline (T0) and after the 8-week intervention (T8). The primary outcome is the change in these blood lipid parameters from baseline to T8. Secondary outcomes include the percentage improvement in the nine-symptom Phlegm-Dampness syndrome score, assessed at baseline and every 15 days during the intervention, and the incidence of treatment-emergent adverse events throughout the 8-week study period.
- Conditions
- Phlegm-Dampness Syndrome
- Being tested
- Auricular Acupressure, Sham Auricular Acupressure, Atorvastatin, Diet and exercise regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureProcedure or surgery
Also called Auricular Therapy, Ear Acupressure, Auricular Pellets
In this study, active semi-permanent auricular needles (auricular pellets) will be applied to 5 therapeutic acupoints: Spleen (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear. Needles will be retained for 5 days to provide continuous stimulation, with the patches replaced on the 6th day. Participants will be prompted to perform self-acupressure on the points 4 times daily (60 seconds per acupoint). The entire procedure totals 12 sessions over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols.
Sham Auricular AcupressureProcedure or surgery
Also called Placebo Auricular Acupressure, Sham Ear Acupressure
Sham auricular acupressure will be performed using auricular pellet patches with the needles completely removed, applied to 3 non-therapeutic ear points: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4) on the left ear. The patches will be replaced on the 6th day, totaling 10 sessions over an 8-week period with alternating ears. The procedure duration and appearance will be identical to the active intervention to maintain blinding, but participants are strictly instructed NOT to perform any self-acupressure.
AtorvastatinDrug
Participants in both groups are prescribed Atorvastatin 20mg to be taken orally at a dose of 1 tablet per day. The medication must be administered consistently every day after dinner. This pharmacological treatment is maintained continuously throughout the 8-week study period to manage and monitor its effects on blood lipid levels.
Diet and exercise regimenBehavioural
Also called Standard Care, Routine Dyslipidemia Management
Participants are instructed to strictly follow a therapeutic lifestyle change regimen throughout the 8-week study period. The dietary component focuses on a lipid-lowering, high-fiber diet, which includes reducing saturated fat intake, limiting dietary cholesterol to less than 300 mg/day, and increasing the consumption of vegetables and fiber-rich foods. The exercise component requires participants to maintain a consistent daily physical activity routine tailored to their health status. Adherence to both diet and exercise guidelines is monitored regularly by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group receive atorvastatin 20 mg orally once daily after dinner and lifestyle guidance consisting of a lipid-lowering, high-fiber diet. In addition, Khanh Phong intradermal auricular needles are applied to five auricular points: Pi (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6a), and Shenmen (TF4). The needles are applied to one ear at each treatment session, with the treated side alternated between sessions. Participants are instructed to press each retained needle for 60 seconds, four times daily at 4-hour intervals. The needles are replaced every 5 days, for a total of 12 treatment sessions during the 8-week intervention. Receives: Procedure: Auricular Acupressure; Drug: Atorvastatin; Behavioral: Diet and exercise regimen |
| Sham Comparator Group | Sham comparator | Participants in the sham comparator group receive atorvastatin 20 mg orally once daily after dinner and the same lifestyle guidance as the experimental group. In addition, sham auricular acupuncture is performed using the same type of intradermal auricular needles used in the experimental group. The needles are inserted at three predefined auricular points considered theoretically unrelated to the treatment of dyslipidemia and Phlegm-Dampness syndrome: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4). The needles are applied to the left ear and replaced every 5 days, for a total of 12 treatment sessions during the 8-week intervention. Participants are not instructed to perform self-acupressure. Receives: Procedure: Sham Auricular Acupressure; Drug: Atorvastatin; Behavioral: Diet and exercise regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Total Cholesterol at Week 8
Serum total cholesterol (TC) is measured in mg/dL at baseline and at Week 8. Change from baseline is calculated as the Week 8 value minus the baseline value (Week 8 - baseline). A negative change indicates a reduction in serum total cholesterol concentration.
Measured: Baseline and Week 8
Secondary outcomes (2)
Percentage Improvement in Phlegm-Dampness Syndrome Clinical Symptom Score
Phlegm-Dampness syndrome clinical symptoms are assessed using a 9-item symptom score based on the Guidelines for Clinical Research on New Chinese Medicine Drugs (Zhongyao Xinyao Linchuang Yanjiu Zhidao Yuanze, 2002), published by the Ministry of Health of the People's Republic of China. The scale assesses nine symptoms: obesity/overweight, heavy sensation in the head, chest tightness, nausea/expectoration of phlegm, numbness of the limbs, palpitations, bland taste in the mouth, reduced appetite, and insomnia. Each item is scored from 0 (absent) to 3 (severe), resulting in a total score ranging from 0 to 27. Higher total scores indicate greater symptom severity and therefore a worse outcome; lower total scores indicate less severe symptoms and therefore a better outcome. The percentage improvement is calculated based on the reduction in the total symptom score from baseline at each assessment time point.
Measured: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
Incidence of treatment-emergent adverse events
To evaluate the safety of the auricular acupressure procedure by recording adverse events (if any).
Measured: Throughout the 8-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Feb 2026
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Phlegm-Dampness SyndromeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Buu Ngoc, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624604
- Sponsor's protocol ID
- 496/HDDD-DHYD
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
PubMed 26673558Song Q, Yuan Y, Jiao C, Zhu X. Curative effect of Tai Chi exercise in combination with auricular plaster therapy on improving obesity patient with secondary hyperlipidemia. Int J Clin Exp Med. 2015 Nov 15;8(11):21386-92. eCollection 2015.
PubMed 26885081Pang T, Liu Z, Xu B. [Clinical observation on obesity and hyperlipidemia of yang deficiency of spleen and kidney syn- drome in female patients treated with warm acupuncture combined with auricular acupuncture]. Zhongguo Zhen Jiu. 2015 Jun;35(6):529-33. Chinese.
PubMed 26480544Yeh ML, Chu NF, Hsu MY, Hsu CC, Chung YC. Acupoint Stimulation on Weight Reduction for Obesity: A Randomized Sham-Controlled Study. West J Nurs Res. 2015 Dec;37(12):1517-30. doi: 10.1177/0193945914548707. Epub 2014 Sep 1.
PubMed 25183702Cha HS, Park H. Effects of auricular acupressure on obesity in adolescents. Complement Ther Clin Pract. 2019 May;35:316-322. doi: 10.1016/j.ctcp.2019.03.014. Epub 2019 Mar 18.
PubMed 31003676Aronow WS. Treatment of high-risk older persons with lipid-lowering drug therapy. Am J Ther. 2008 Mar-Apr;15(2):102-7. doi: 10.1097/MJT.0b013e31802b5aa4.
PubMed 18356628Zhang T, Chen J, Tang X, Luo Q, Xu D, Yu B. Interaction between adipocytes and high-density lipoprotein:new insights into the mechanism of obesity-induced dyslipidemia and atherosclerosis. Lipids Health Dis. 2019 Dec 16;18(1):223. doi: 10.1186/s12944-019-1170-9.
PubMed 31842884Wang K, Liu Z, Xu B. [Impact on the lipid level of obesity of spleen deficiency and damp blockage complicated by hyperlipemia treated with warm needling therapy and auricular acupuncture]. Zhongguo Zhen Jiu. 2016 Mar;36(3):225-30. Chinese.
PubMed 27344822Ismail LA, Ibrahim AA, Abdel-Latif GA, El-Haleem DA, Helmy G, Labib LM, El-Masry MK. Effect of Acupuncture on Body Weight Reduction and Inflammatory Mediators in Egyptian Obese Patients. Open Access Maced J Med Sci. 2015 Mar 15;3(1):85-90. doi: 10.3889/oamjms.2015.010. Epub 2015 Jan 14.
PubMed 27275202Liu X, Chen K, Chen F. Clinical efficacy and safety of acupuncture combined with statin in dyslipidemia: A meta-analysis and system review. Medicine (Baltimore). 2024 Sep 13;103(37):e39663. doi: 10.1097/MD.0000000000039663.
PubMed 39287278
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Managing Blood Lipid Levels and Improving Phlegm-Dampness Symptoms in 80 Patients With Dyslipidemia and Phlegm-Dampness Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07624604
- Acronym / sponsor ID
- 496/HDDD-DHYD
- Conditions
- Phlegm-Dampness Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 3 Jun 2026 (actual)
- 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.
Dyslipidemia (DL) is a metabolic disorder characterized by abnormal levels of blood lipids and is an important risk factor for cardiovascular disease. Although current management primarily relies on lifestyle modification and lipid-lowering medications, particularly statins, some patients may have an inadequate treatment response, experience adverse effects, or have difficulty maintaining long-term adherence.
Traditional Chinese Medicine therapies are increasingly used as complementary approaches to conventional treatment. Auricular acupuncture, which stimulates specific acupoints on the ear, has been investigated for its potential effects on lipid metabolism. In Traditional Chinese Medicine, Phlegm-Dampness syndrome is considered a common syndrome pattern associated with dyslipidemia. However, clinical evidence regarding the effects of auricular acupuncture on blood lipid parameters and Phlegm-Dampness symptoms in patients with dyslipidemia remains limited, particularly in Vietnam.
This randomized controlled trial evaluates the effects of auricular acupuncture combined with atorvastatin compared with atorvastatin plus sham auricular acupuncture in patients with dyslipidemia presenting with Phlegm-Dampness syndrome. The primary outcome is the change in blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), from baseline to the end of the 8-week intervention. Changes in clinical symptoms of Phlegm-Dampness syndrome are also evaluated.
Detailed description
This single-blind, randomized, sham-controlled clinical trial includes 80 outpatients aged 18 years or older with dyslipidemia presenting with Phlegm-Dampness syndrome at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. Only participants are blinded to group allocation. Participants are randomly assigned to two equal groups. Both groups receive atorvastatin 20 mg once daily after dinner and are advised to follow a lipid-lowering, high-fiber diet.
The intervention group receives Khanh Phong intradermal auricular needles applied to five auricular acupoints: Pi (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6a), and Shenmen (TF4). The therapeutic points are selected according to traditional medicine treatment principles for Phlegm-Dampness syndrome and the Vietnamese traditional medicine guideline. Participants are instructed to perform self-acupressure four times daily. The control group receives sham auricular acupuncture performed by inserting the same type of intradermal auricular needles used in the intervention group at three predefined auricular points considered theoretically unrelated to the treatment of dyslipidemia and Phlegm-Dampness syndrome: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4). Participants in the control group are not instructed to perform self-acupressure.
The intervention period lasts 8 weeks. In both groups, intradermal auricular needles are applied at the initial treatment session and subsequently replaced every 5 days, for a total of 12 treatment sessions. In the intervention group, the treated ear is alternated between sessions; in the control group, the needles are applied to the left ear. Participants are monitored for 15 minutes after each procedure and are instructed regarding monitoring for potential adverse events, including fainting, localized pain or swelling, ear bleeding, infection, and perichondritis.
Blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), are measured at baseline (T0) and after the 8-week intervention (T8). The primary outcome is the change in these blood lipid parameters from baseline to T8. Secondary outcomes include the percentage improvement in the nine-symptom Phlegm-Dampness syndrome score, assessed at baseline and every 15 days during the intervention, and the incidence of treatment-emergent adverse events throughout the 8-week study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Auricular Acupressure, Drug: Atorvastatin, Behavioral: Diet and exercise regimenParticipants in the experimental group receive atorvastatin 20 mg orally once daily after dinner and lifestyle guidance consisting of a lipid-lowering, high-fiber diet. In addition, Khanh Phong intradermal auricular needles are applied to five auricular points: Pi (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6a), and Shenmen (TF4). The needles are applied to one ear at each treatment session, with the treated side alternated between sessions. Participants are instructed to press each retained needle for 60 seconds, four times daily at 4-hour intervals. The needles are replaced every 5 days, for a total of 12 treatment sessions during the 8-week intervention. |
| Sham Comparator Group | Sham comparator | Procedure: Sham Auricular Acupressure, Drug: Atorvastatin, Behavioral: Diet and exercise regimenParticipants in the sham comparator group receive atorvastatin 20 mg orally once daily after dinner and the same lifestyle guidance as the experimental group. In addition, sham auricular acupuncture is performed using the same type of intradermal auricular needles used in the experimental group. The needles are inserted at three predefined auricular points considered theoretically unrelated to the treatment of dyslipidemia and Phlegm-Dampness syndrome: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4). The needles are applied to the left ear and replaced every 5 days, for a total of 12 treatment sessions during the 8-week intervention. Participants are not instructed to perform self-acupressure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis: Dyslipidemia (DL), untreated or discontinued treatment for at least 1 month, and not taking drugs that induce DL.
- Laboratory Criteria: LDL-c levels between 2.6 and 4.9 mmol/L.
- TCM Criteria:
- Diagnosed with Phlegm-Dampness syndrome in patients with DL according to the "Guiding Principles for Clinical Research on Combined Traditional Chinese and Western Medicine":
- Primary symptoms: Obesity, heavy sensation in the head, chest tightness, nausea/phlegm expectoration, numbness in limbs.
Key exclusion criteria (3 listed)
- Participants are non-compliant with the treatment protocol.
- Participants decline to continue study participation for any reason (Withdrawal of consent).
- Participants experience health events during the study and do not wish to continue participation.
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 |
|---|---|---|
| Auricular AcupressureAlso: Auricular Therapy, Ear Acupressure, Auricular PelletsIn this study, active semi-permanent auricular needles (auricular pellets) will be applied to 5 therapeutic acupoints: Spleen (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear. Needles will be retained for 5 days to provide continuous stimulation, with the patches replaced on the 6th day. Participants will be prompted to perform self-acupressure on the points 4 times daily (60 seconds per acupoint). The entire procedure totals 12 sessions over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols. | Procedure or surgery | Experimental Group |
| Sham Auricular AcupressureAlso: Placebo Auricular Acupressure, Sham Ear AcupressureSham auricular acupressure will be performed using auricular pellet patches with the needles completely removed, applied to 3 non-therapeutic ear points: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4) on the left ear. The patches will be replaced on the 6th day, totaling 10 sessions over an 8-week period with alternating ears. The procedure duration and appearance will be identical to the active intervention to maintain blinding, but participants are strictly instructed NOT to perform any self-acupressure. | Procedure or surgery | Sham Comparator Group |
| AtorvastatinParticipants in both groups are prescribed Atorvastatin 20mg to be taken orally at a dose of 1 tablet per day. The medication must be administered consistently every day after dinner. This pharmacological treatment is maintained continuously throughout the 8-week study period to manage and monitor its effects on blood lipid levels. | Drug | Experimental Group, Sham Comparator Group |
| Diet and exercise regimenAlso: Standard Care, Routine Dyslipidemia ManagementParticipants are instructed to strictly follow a therapeutic lifestyle change regimen throughout the 8-week study period. The dietary component focuses on a lipid-lowering, high-fiber diet, which includes reducing saturated fat intake, limiting dietary cholesterol to less than 300 mg/day, and increasing the consumption of vegetables and fiber-rich foods. The exercise component requires participants to maintain a consistent daily physical activity routine tailored to their health status. Adherence to both diet and exercise guidelines is monitored regularly by the research team. | Behavioural | Experimental Group, Sham Comparator Group |
Primary outcome
Mean Change From Baseline in Total Cholesterol at Week 8
Time frame: Baseline and Week 8
Serum total cholesterol (TC) is measured in mg/dL at baseline and at Week 8. Change from baseline is calculated as the Week 8 value minus the baseline value (Week 8 - baseline). A negative change indicates a reduction in serum total cholesterol concentration.
2 secondary outcomes
Percentage Improvement in Phlegm-Dampness Syndrome Clinical Symptom Score
Time frame: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
Incidence of treatment-emergent adverse events
Time frame: Throughout the 8-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- Results publication: PubMed 26673558Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Results publication: PubMed 26885081Song Q, Yuan Y, Jiao C, Zhu X. Curative effect of Tai Chi exercise in combination with auricular plaster therapy on improving obesity patient with secondary hyperlipidemia. Int J Clin Exp Med. 2015 Nov 15;8(11):21386-92. eCollection 2015.
- Results publication: PubMed 26480544Pang T, Liu Z, Xu B. [Clinical observation on obesity and hyperlipidemia of yang deficiency of spleen and kidney syn- drome in female patients treated with warm acupuncture combined with auricular acupuncture]. Zhongguo Zhen Jiu. 2015 Jun;35(6):529-33. Chinese.
- Results publication: PubMed 25183702Yeh ML, Chu NF, Hsu MY, Hsu CC, Chung YC. Acupoint Stimulation on Weight Reduction for Obesity: A Randomized Sham-Controlled Study. West J Nurs Res. 2015 Dec;37(12):1517-30. doi: 10.1177/0193945914548707. Epub 2014 Sep 1.
- Results publication: PubMed 31003676Cha HS, Park H. Effects of auricular acupressure on obesity in adolescents. Complement Ther Clin Pract. 2019 May;35:316-322. doi: 10.1016/j.ctcp.2019.03.014. Epub 2019 Mar 18.
- Results publication: PubMed 18356628Aronow WS. Treatment of high-risk older persons with lipid-lowering drug therapy. Am J Ther. 2008 Mar-Apr;15(2):102-7. doi: 10.1097/MJT.0b013e31802b5aa4.
- Results publication: PubMed 31842884Zhang T, Chen J, Tang X, Luo Q, Xu D, Yu B. Interaction between adipocytes and high-density lipoprotein:new insights into the mechanism of obesity-induced dyslipidemia and atherosclerosis. Lipids Health Dis. 2019 Dec 16;18(1):223. doi: 10.1186/s12944-019-1170-9.
- Results publication: PubMed 27344822Wang K, Liu Z, Xu B. [Impact on the lipid level of obesity of spleen deficiency and damp blockage complicated by hyperlipemia treated with warm needling therapy and auricular acupuncture]. Zhongguo Zhen Jiu. 2016 Mar;36(3):225-30. Chinese.
- Results publication: PubMed 27275202Ismail LA, Ibrahim AA, Abdel-Latif GA, El-Haleem DA, Helmy G, Labib LM, El-Masry MK. Effect of Acupuncture on Body Weight Reduction and Inflammatory Mediators in Egyptian Obese Patients. Open Access Maced J Med Sci. 2015 Mar 15;3(1):85-90. doi: 10.3889/oamjms.2015.010. Epub 2015 Jan 14.
- Results publication: PubMed 39287278Liu X, Chen K, Chen F. Clinical efficacy and safety of acupuncture combined with statin in dyslipidemia: A meta-analysis and system review. Medicine (Baltimore). 2024 Sep 13;103(37):e39663. doi: 10.1097/MD.0000000000039663.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure, Atorvastatin and Diet and exercise regimen in people with Phlegm-Dampness Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Total Cholesterol at Week 8 (time frame: Baseline and Week 8). 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 NCT07624604, which also lists 11 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 10 Sep 2026.