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

3 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: True Auricular Acupressure
Application of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.
Droga: Loratadine 10mg
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
Comparatore fittizio: 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.
Droga: Loratadine 10mg
Standard antihistamine therapy administered orally, 10mg once daily after breakfast.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Urticaria Activity Score 7 (UAS7)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Dermatology Life Quality Index (DLQI)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

3 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 736/DHYD-HDDD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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