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

3 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

66

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Huy Chung Ly, MD, PhD
  • Número de teléfono: +84989974868
  • Correo electrónico: lychunghuy@ump.edu.vn

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Comparador falso: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Urticaria Activity Score 7 (UAS7)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Dermatology Life Quality Index (DLQI)
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de mayo de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2026

Publicado por primera vez (Actual)

8 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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