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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  • 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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Verfahren: 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.
Andere Namen:
  • Ohr -Akupressur
  • Auricular Therapy
  • Auricular Pellets
Arzneimittel: 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.
Verhalten: 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.
Andere Namen:
  • Standardpflege
  • Routine Dyslipidemia Management
Schein-Komparator: 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.
Arzneimittel: 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.
Verhalten: 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.
Andere Namen:
  • Standardpflege
  • Routine Dyslipidemia Management
Verfahren: 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.
Andere Namen:
  • Schein -Ohr -Akupressur
  • Placebo Auricular Acupressure

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in Phlegm-Dampness syndrome clinical symptom score
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in blood lipid profiles
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 496/HDDD-DHYD

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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