Evaluation of the Therapeutic Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Patients With Dyslipidemia and Phlegm-Dampness Syndrome
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Hồ Chí Minh, Вьетнам
- Bệnh viện Lê Văn Thịnh
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental Group
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.
|
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.
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.
Другие имена:
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.
Другие имена:
|
|
Фальшивый компаратор: Sham Comparator Group
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.
|
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.
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.
Другие имена:
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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Change From Baseline in Total Cholesterol at Week 8
Временное ограничение: 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.
|
Baseline and Week 8
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of treatment-emergent adverse events
Временное ограничение: 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
|
|
Percentage Improvement in Phlegm-Dampness Syndrome Clinical Symptom Score
Временное ограничение: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
|
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.
|
Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
- Writing 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.
- Song 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.
- Pang 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.
- Yeh 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.
- Cha 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.
- Aronow 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.
- Zhang 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.
- Wang 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.
- Ismail 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.
- Liu 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Администрация медицинских услуг
- Качество, доступ и оценка здравоохранения
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Жирные кислоты
- Липиды
- Азолы
- Качество здравоохранения
- Диета, еда и питание
- Физиологические явления
- Индикаторы качества, здравоохранение
- Пищевые физиологические явления
- Пирролы
- Гептановые кислоты
- Аторвастатин
- Стандарт ухода
- Диета
Другие идентификационные номера исследования
- 496/HDDD-DHYD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .