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Evaluation of the Therapeutic Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Patients With Dyslipidemia and Phlegm-Dampness Syndrome

28. května 2026 aktualizováno: To Buu Ngoc, University of Medicine and Pharmacy at Ho Chi Minh City

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 an imbalance of blood lipid components, serving as a leading silent cause of dangerous cardiovascular diseases and increased mortality risk globally. According to the World Health Organization (WHO), cardiovascular diseases account for 32% of all deaths worldwide, with dyslipidemia playing a crucial role in the pathogenesis of 85% of fatalities caused by heart attacks and strokes. Although current management primarily relies on lifestyle modifications and lipid-lowering medications such as statins, fibrates, or niacin, some patients still encounter difficulties due to inadequate treatment response, adverse side effects, or poor long-term compliance. In this context, Traditional Chinese Medicine (TCM) therapies are increasingly being widely applied, either as monotherapy or in combination with Western medicine. Notably, auricular acupuncture-a method focusing on specific acupoints on the ear-has been recognized for its great potential in modulating lipid profiles, particularly demonstrating therapeutic efficacy in patients with Phlegm-Dampness syndrome.

Theoretically and clinically, Phlegm-Dampness syndrome is inextricably linked to the pathogenesis and progression of dyslipidemia (DL); furthermore, clinical research in China indicates that the Phlegm pattern accounts for the highest proportion among the five traditional syndromes of this condition, and a greater severity of Phlegm-Dampness correlates positively with higher levels of TC and LDL-c. In terms of treatment, auricular pellets (a modality of auricular acupuncture) have been demonstrated to improve cardiovascular health by reducing TC, LDL-c, and TGR levels while elevating HDL-c in obese patients with mild-to-moderate DL. In Vietnam, however, studies evaluating the application of auricular pellets in patients with DL remain limited, primarily focusing on individuals with simple overweight or obesity without documented concurrent metabolic disorders. Notably, a study by Nguyen Vu Thien Duyen (2021) reported that a 3-acupoint formula consisting of Hunger (TGR3), Stomach (CO4), and Endocrine (CO18) effectively reduced lipid profiles to a moderate extent in obese individuals.

Given the limitations in evaluating therapeutic efficacy and the scarcity of published studies discussing the effects of lowering blood lipid profiles and alleviating Phlegm-Dampness symptoms for this specific pattern in Vietnam, the investigators conducted this study to evaluate the degree of lipid profile reduction and the clinical symptom improvement of the Phlegm-Dampness syndrome using auricular acupuncture in patients with dyslipidemia presenting with the Phlegm-Dampness syndrome.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

  • This single-blind, randomized clinical trial is conducted on 80 outpatients aged 18 years or older with simple dyslipidemia presenting with Phlegm-Dampness syndrome at Le Van Thinh Hospital and Ho Chi Minh City Traditional Medicine Hospital. Participants are randomly assigned into two equal groups, both of which maintain a daily regimen of Atorvastatin 20mg (taken after dinner) and adhere to a lipid-lowering, high-fiber diet. The intervention group receives Khanh Phong auricular pellets implemented at 5 specific acupoints, including Spleen (CO11), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear, and is instructed to perform self-acupressure 4 times daily. Meanwhile, the control group undergoes a sham auricular procedure using pellet patches with the needles removed, applied at 3 non-specific technical points, including Finger (SF1), Thoracic Spine (AH11), and Knee (AH4), with absolutely no acupressure performed.
  • The intervention period lasts continuously for 8 weeks, with a frequency of replacing the pellets or sham patches once every 5 days on the 6th day, totaling 10 sessions with alternating ears. Patients are strictly monitored for 15 minutes post-procedure and supervised at home to tightly control potential adverse events such as needle fainting, localized pain and swelling, ear bleeding, infection, or perichondritis. The study outcomes are evaluated based on the improvement rate of the total score of 9 clinical symptoms of Phlegm-Dampness syndrome assessed periodically every 15 days, alongside changes in blood lipid profiles (TC, TGR, LDL-c, HDL-c) measured and compared at two distinct time points: pre-intervention (D0) and post-8-week intervention (D60).

Typ studie

Intervenční

Zápis (Odhadovaný)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Experimental Group
The intervention group receives Atorvastatin 20mg (1 tablet/day, orally after dinner) combined with a lipid-lowering, high-fiber diet . Additionally, active auricular pellets are applied once every 5 days at 5 specific acupoints, including Spleen (CO11), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear, with the patches replaced on the 6th day . Patients are instructed to perform self-acupressure 4 times daily (60 seconds per acupoint) to create stimulation . The entire procedure totals 10 sessions over an 8-week period, with the diet and exercise regimen maintained throughout the study
Postup: Auricular Acupressure
In this study, active semi-permanent auricular needles (auricular pellets) will be applied to 5 therapeutic acupoints: Spleen (CO11), 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 10 sessions over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols.
Ostatní jména:
  • Akupresura uší
  • Auricular Therapy
  • Auricular Pellets
Lék: Atorvastatin
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.
Behaviorální: Diet and exercise regimen
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.
Ostatní jména:
  • Standardní péče
  • Routine Dyslipidemia Management
Falešný srovnávač: Sham Comparator Group
The control group receives Atorvastatin 20mg (1 tablet/day, orally after dinner) combined with a lipid-lowering and high-fiber diet. Additionally, sham auricular procedures are administered once every 5 days on the left ear using pellet patches with the needles completely removed. These sham patches are applied at 3 non-specific technical points, including Finger (SF1), Thoracic Spine (AH11), and Knee (AH4), and patients are strictly instructed NOT to perform any self-acupressure or manual stimulation. The treatment process consists of a total of 10 sessions over an 8-week period, with the patches replaced on the 6th day of each cycle and alternating ears between sessions. The dietary and exercise regimen is strictly maintained throughout the study period.
Lék: Atorvastatin
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.
Behaviorální: Diet and exercise regimen
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.
Ostatní jména:
  • Standardní péče
  • Routine Dyslipidemia Management
Postup: Sham Auricular 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.
Ostatní jména:
  • Sham Acupressure
  • Placebo Auricular Acupressure

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in Phlegm-Dampness syndrome clinical symptom score
Časové okno: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
To compare the improvement rate of clinical symptoms of Phlegm-Dampness syndrome between auricular acupressure combined with Atorvastatin and sham auricular acupressure combined with Atorvastatin in dyslipidemia patients every 15 days.
Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in blood lipid profiles
Časové okno: Baseline and Week 8
To compare the changes in blood lipid profiles (including Total Cholesterol [TC], Triglycerides [TG], Low-Density Lipoprotein Cholesterol [LDL-c], and High-Density Lipoprotein Cholesterol [HDL-c]) between auricular acupressure combined with Atorvastatin and sham auricular acupressure combined with Atorvastatin in dyslipidemia patients after 8 weeks.
Baseline and Week 8
Incidence of treatment-emergent adverse events
Časové okno: Throughout the 8-week study period
To evaluate the safety of the auricular acupressure procedure by recording adverse events (if any).
Throughout the 8-week study period

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Medicine and Pharmacy at Ho Chi Minh City

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

1. října 2026

Dokončení studie (Odhadovaný)

1. října 2026

Termíny zápisu do studia

První předloženo

28. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 2026

První zveřejněno (Aktuální)

3. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 496/HDDD-DHYD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Klinické studie na Auricular Acupressure

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