The purpose of this clinical trial is to evaluate the efficacy of auricular acupressure combined with an antihistamine (Loratadine) in treating patients diagnosed with Wind-Heat type urticaria. Participants will be randomly assigned to either the intervention group or the control group.
The purpose of this clinical trial is to evaluate the efficacy of auricular acupressure combined with an antihistamine (Loratadine) in treating patients diagnosed with Wind-Heat type urticaria. Participants will be randomly assigned to either the intervention group or the control group.
The main questions the study aims to answer are:
* Does true auricular acupressure combined with Loratadine reduce urticaria symptoms (measured by the Urticaria Activity Score - UAS) more effectively than sham acupressure with Loratadine? * Does the intervention improve the patients' quality of life (measured by the Dermatology Life Quality Index - DLQI) better than the control treatment? * Are there any adverse effects associated with the auricular acupressure treatment during the intervention period?
Participants will:
* Take a standard daily dose of oral Loratadine (10mg). * Visit the clinic once a week for 4 weeks to have Vaccaria seed patches applied to their ear (either true therapeutic points or sham points, depending on their assigned group). * Self-stimulate the acupoints by pressing the patches for 1 to 2 minutes, 2 to 3 times a day at home. * Record their daily urticaria symptoms (wheals and pruritus) using the Urticaria Activity Score (UAS). * Complete the Dermatology Life Quality Index (DLQI) questionnaire at the beginning and at the end of the 4-week study period.
Diagnosed with urticaria according to the international EAACI/GA²LEN/EuroGuiDerm/APAAACI 2022 guidelines.
Presenting typical clinical symptoms of urticaria.
Experiencing persistent itching and wheals, with an Urticaria Activity Score (UAS) indicating an itching and discomfort level of ≥ 1.
Diagnosed with the Wind-Heat syndrome according to Traditional Medicine criteria by a certified practitioner. Diagnosis requires the presence of main symptoms (persistent itchy rash, intense itching, bright red wheals) and at least 2 secondary symptoms (restlessness, feverish sensation, aversion to heat, sore throat, symptoms worsening with heat, thin yellow tongue coating, floating rapid pulse).
Having contraindications to auricular acupressure according to the Ministry of Health, including severe physical exhaustion or immunodeficiency.
Having skin infections, inflammation, or ulceration at the auricular acupoint areas.
Experiencing acute pain suspected to be of surgical origin or in an emergency condition.
Pregnant women.
Parallel
True Auricular Acupressure
Procedure/SurgeryApplication of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.
Sham Auricular Acupressure
Procedure/SurgeryApplication of Vaccaria seed patches to non-therapeutic ear points (Helix 2, Shoulder, Eye, Clavicle, Tooth) to simulate the true intervention without the therapeutic effect.
Loratadine 10mg
DrugStandard antihistamine therapy administered orally, 10mg once daily after breakfast.
Change in Urticaria Activity Score 7 (UAS7)
The UAS7 is used to assess the severity of urticaria symptoms, specifically daily wheals (scored 0-3) and pruritus (scored 0-3). Patients self-evaluate these two symptoms every 24 hours. The daily score ranges from 0 to 6, and the UAS7 is the sum of these daily scores over 7 consecutive days, with a total possible score ranging from 0 to 42. Higher scores indicate more severe disease activity.
Change in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item questionnaire designed to measure the impact of skin disease on a patient's quality of life. Each question is scored on a 4-point Likert scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on the patient's quality of life.
Incidence of Adverse Events Associated with Auricular Acupressure
The number of participants experiencing any adverse events related to the auricular acupressure intervention, such as local pain, bleeding, skin infection, cartilage damage, or fainting (vertigo). These will be monitored continuously throughout the 4-week study period.
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