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

2026년 5월 3일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

66

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
Application of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
가짜 비교기: 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.
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Urticaria Activity Score 7 (UAS7)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Dermatology Life Quality Index (DLQI)
기간: 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
기간: 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.

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간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 3일

QC 기준을 충족하는 최초 제출

2026년 5월 3일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 3일

마지막으로 확인됨

2026년 5월 1일

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True Auricular Acupressure에 대한 임상 시험

구독하다