Not Yet RecruitingNot Applicable

Efficacy of Auricular Acupressure Combined With Antihistamines in Patients With Wind-Heat Type Urticaria.

Vietnam66 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * Voluntarily agrees to participate and signs the informed consent form. Exclusion Criteria: * 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. * Use of stimulants (alcohol, beer, coffee, tobacco) within 24 hours prior to the study intervention. * Severe cognitive impairment or inability to understand the study protocol. * History of allergy or hypersensitivity to second-generation H1 antihistamines. * Currently participating in another interventional clinical study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Urticaria Activity Score 7 (UAS7)

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.

Trial details

NCT IDNCT07575464

SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Phong Minh Cao, MD

+84336244087 cmphong.ths.yhct24@ump.edu.vn

View on ClinicalTrials.gov More Auricular Acupressure trials