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

NCT07575464 | Not Yet Recruiting

• 1 other identifier: 736/DHYD-HDDD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Auricular Acupressure; Wind-Heat Urticaria; Traditional Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Change in Dermatology Life Quality Index (DLQI)

  Baseline (Week 0) and Week 4.

• Incidence of Adverse Events Associated with Auricular Acupressure

  Up to 4 weeks.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Drug: Loratadine 10mg

Control Group

SHAM COMPARATOR

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.

Procedure: Sham Auricular Acupressure; Drug: Loratadine 10mg

Interventions

True Auricular Acupressure PROCEDURE

Application of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.

Intervention Group

Sham Auricular Acupressure PROCEDURE

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.

Control Group

Loratadine 10mg DRUG

Standard antihistamine therapy administered orally, 10mg once daily after breakfast.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Department of Obstetrics, Le Van Thinh Hospital

Ho Chi Minh City, Vietnam

Location

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MeSH Terms

Interventions

Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Phong Minh Cao, MD

CONTACT

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

Huy Chung Ly, MD, PhD

CONTACT

+84989974868; lychunghuy@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind study: Participants are randomly assigned to either the true auricular acupressure group or the sham auricular acupressure group. Participants are blinded to their group assignment because the sham intervention uses the exact same type of patches (Vaccaria seeds) applied to non-therapeutic, alternative areas of the ear, creating the identical physical sensation as the true treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)