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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
‐ This single‐blind, randomized clinical trial is conducted on 80 outpatients aged 18years or older with simple dyslipidemia presenting with Phlegm‐Dampness syndrome atLe Van Thinh Hospital and Ho Chi Minh City Traditional Medicine Hospital.Participants are randomly assigned into two equal groups, both of which maintain adaily regimen of Atorvastatin 20mg (taken after dinner) and adhere to alipid‐lowering, high‐fiber diet. The intervention group receives Khanh Phongauricular pellets implemented at 5 specific acupoints, including Spleen (CO11),Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) onthe left ear, and is instructed to perform self‐acupressure 4 times daily.Meanwhile, the control group undergoes a sham auricular procedure using pelletpatches with the needles removed, applied at 3 non‐specific technical points,including Finger (SF1), Thoracic Spine (AH11), and Knee (AH4), with absolutely noacupressure performed. ‐ The intervention period lasts continuously for 8 weeks, with a frequency ofreplacing the pellets or sham patches once every 5 days on the 6th day, totaling 10sessions with alternating ears. Patients are strictly monitored for 15 minutespost‐procedure and supervised at home to tightly control potential adverse eventssuch as needle fainting, localized pain and swelling, ear bleeding, infection, orperichondritis. The study outcomes are evaluated based on the improvement rate ofthe total score of 9 clinical symptoms of Phlegm‐Dampness syndrome assessedperiodically 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).
Epistemonikos ID: c1733226bc1dbf9314d8e506f7456ac0b1121d51
First added on: Jun 04, 2026