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

May 3, 2026 updated by: Cao Minh Phong, University of Medicine and Pharmacy at Ho Chi Minh City

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, single-blind, controlled clinical trial designed to assess the therapeutic effects of auricular acupressure in patients with Wind-Heat type urticaria. The study will recruit 66 eligible patients at the Dermatology Department of Le Van Thinh Hospital. Participants will be randomly allocated into two equal groups (33 patients per group):

  • Intervention Group: Patients will receive a standard oral dose of Loratadine (10mg/day) and undergo true auricular acupressure. Vaccaria seeds (Vương bất lưu hành) will be taped to five specific acupoints: Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Adrenal (TG2), and Lung (CO14).
  • Control Group: Patients will receive a standard oral dose of Loratadine (10mg/day) and undergo sham auricular acupressure. Vaccaria seeds will be taped to five non-therapeutic points: Helix 2 (HX10), Shoulder (SF4), Eye (LO5), Clavicle (SF6), and Tooth (LO1).

Study Procedures:

- In both groups, the auricular acupressure patches will be applied by a qualified practitioner. Patients will be instructed to stimulate the acupoints by pressing each patch for 1 to 2 minutes, 2 to 3 times daily. The patches will remain on one ear for 7 days. At weekly follow-up visits, the old patches will be removed, and new patches will be applied to the opposite ear. The total intervention period is 4 weeks (4 sessions).

Outcome Assessments:

  • Primary Outcome: The primary efficacy measure is the reduction in clinical symptoms, assessed using the Urticaria Activity Score 7 (UAS7). Patients will self-evaluate their daily wheals and pruritus, and the total score will be recorded weekly from baseline (T0) to week 4 (T1, T2, T3, T4).
  • Secondary Outcome: The impact on the patients' quality of life will be evaluated using the Dermatology Life Quality Index (DLQI) questionnaire. This will be assessed at baseline (T0) and at the end of the 4-week treatment period (T4).
  • Safety Monitoring: Any adverse events associated with auricular acupressure (such as local pain, bleeding, skin infection, cartilage damage, fainting, or vertigo) will be closely monitored, recorded, and managed appropriately during the 30-minute post-application observation period and throughout the 4-week study duration.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Department of Obstetrics, Le Van Thinh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients receive a standard oral dose of Loratadine (10mg/day) and undergo true auricular acupressure. Vaccaria seed patches are applied to five specific therapeutic acupoints: Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Adrenal (TG2), and Lung (CO14). The patches are worn continuously, replaced weekly on the opposite ear, and patients self-press the patches 1-2 minutes, 2-3 times daily. Duration: 4 weeks.
Procedure: True Auricular Acupressure
Application of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.
Drug: Loratadine 10mg
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
Sham Comparator: Control Group
Patients receive the same standard oral dose of Loratadine (10mg/day) and undergo sham auricular acupressure. Vaccaria seed patches are applied to five non-therapeutic points: Helix 2 (HX10), Shoulder (SF4), Eye (LO5), Clavicle (SF6), and Tooth (LO1). The patches are worn continuously, replaced weekly on the opposite ear, and patients self-press the patches 1-2 minutes, 2-3 times daily. Duration: 4 weeks.
Drug: Loratadine 10mg
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
Procedure: Sham Auricular Acupressure
Application of Vaccaria seed patches to non-therapeutic ear points (Helix 2, Shoulder, Eye, Clavicle, Tooth) to simulate the true intervention without the therapeutic effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urticaria Activity Score 7 (UAS7)
Time Frame: Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.
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.
Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dermatology Life Quality Index (DLQI)
Time Frame: Baseline (Week 0) and Week 4.
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.
Baseline (Week 0) and Week 4.
Incidence of Adverse Events Associated with Auricular Acupressure
Time Frame: Up to 4 weeks.
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.
Up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 3, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 736/DHYD-HDDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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