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

Official title

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

Overview

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.

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.

Interventions

• Procedure True Auricular Acupressure
  Application of Vaccaria seed patches to therapeutic ear acupoints (Shenmen, Sympathetic, Endocrine, Adrenal, Lung) with daily self-acupressure.
• 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.
• Drug Loratadine 10mg
  Standard antihistamine therapy administered orally, 10mg once daily after breakfast.

Primary outcome measures

• Change in Urticaria Activity Score 7 (UAS7) [Time frame: Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.]

Secondary outcome measures (2)

• Change in Dermatology Life Quality Index (DLQI) [Time frame: Baseline (Week 0) and Week 4.]
• Incidence of Adverse Events Associated with Auricular Acupressure [Time frame: Up to 4 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 1 center

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

Publications

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• Hamill ME, Collin GR, Bath JL, Boone SM, Harvey EM, Tegge AN, Sprinkel WE, Toomey SA, Collier BR, Bower KL, Wang MM, Faulks ER, Matos MA, Hamill BE, Bean SL, Nussbaum MS, Parker SH. Impact of Standardized Multidisciplinary Critical Care Training on Confidence with Critical Illness and Attitudes Towards Interprofessional Education and Multidisciplinary Care. J Intensive Care Med. 2024 Apr;39(4):320 PMID 37812739
• Bernstein JA, Lang DM, Khan DA, Craig T, Dreyfus D, Hsieh F, Sheikh J, Weldon D, Zuraw B, Bernstein DI, Blessing-Moore J, Cox L, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CR, Schuller DE, Spector SL, Tilles SA, Wallace D. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014 May;133(5):1270-7. doi: 10.1016/j.jaci.2014.02.036. PMID 24766875
• Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, Bernstein JA, Bindslev-Jensen C, Brzoza Z, Buense Bedrikow R, Canonica GW, Church MK, Craig T, Danilycheva IV, Dressler C, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Katelaris CH, Kocaturk E, Kulthanan K, Larenas-Linnemann D, Leslie TA, Magerl M, Mathelier-Fusade P, Meshko PMID 29336054
• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. PMID 8033378

Identifiers

NCT: NCT07575464 · 736/DHYD-HDDD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗