- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07575464
Efficacy of Auricular Acupressure Combined With Antihistamines in Patients With Wind-Heat Type Urticaria.
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
Estado
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
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
- Nombre: Phong Minh Cao, MD
- Número de teléfono: +84336244087
- Correo electrónico: cmphong.ths.yhct24@ump.edu.vn
Ubicaciones de estudio
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Ho Chi Minh City, Vietnam
- Department of Obstetrics, Le Van Thinh Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
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
¿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 |
|---|---|
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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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Urticaria Activity Score 7 (UAS7)
Periodo de tiempo: Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.
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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.
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Baseline (Week 0), Week 1, Week 2, Week 3, and Week 4.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dermatology Life Quality Index (DLQI)
Periodo de tiempo: Baseline (Week 0) and Week 4.
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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.
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Baseline (Week 0) and Week 4.
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Incidence of Adverse Events Associated with Auricular Acupressure
Periodo de tiempo: Up to 4 weeks.
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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.
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Up to 4 weeks.
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Karimkhani C, Dellavalle RP, Coffeng LE, Flohr C, Hay RJ, Langan SM, Nsoesie EO, Ferrari AJ, Erskine HE, Silverberg JI, Vos T, Naghavi M. Global Skin Disease Morbidity and Mortality: An Update From the Global Burden of Disease Study 2013. JAMA Dermatol. 2017 May 1;153(5):406-412. doi: 10.1001/jamadermatol.2016.5538.
- El Chaer F, Ballen KK. Treatment of acute leukaemia in adult Jehovah's Witnesses. Br J Haematol. 2020 Sep;190(5):696-707. doi: 10.1111/bjh.16284. Epub 2019 Nov 6.
- Palm D, Uzoni A, Simon F, Fischer M, Coogan A, Tucha O, Thome J, Faltraco F. Evolutionary conservations, changes of circadian rhythms and their effect on circadian disturbances and therapeutic approaches. Neurosci Biobehav Rev. 2021 Sep;128:21-34. doi: 10.1016/j.neubiorev.2021.06.007. Epub 2021 Jun 5.
- Tur E, Brenner S. Diet and pemphigus. In pursuit of exogenous factors in pemphigus and fogo selvagem. Arch Dermatol. 1998 Nov;134(11):1406-10. doi: 10.1001/archderm.134.11.1406.
- 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):320-327. doi: 10.1177/08850666231201528. Epub 2023 Oct 9.
- 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.
- 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, Meshkova RY, Metz M, Nast A, Nettis E, Oude-Elberink H, Rosumeck S, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Staubach P, Sussman G, Toubi E, Vena GA, Vestergaard C, Wedi B, Werner RN, Zhao Z, Maurer M; Endorsed by the following societies: AAAAI, AAD, AAIITO, ACAAI, AEDV, APAAACI, ASBAI, ASCIA, BAD, BSACI, CDA, CMICA, CSACI, DDG, DDS, DGAKI, DSA, DST, EAACI, EIAS, EDF, EMBRN, ESCD, GA(2)LEN, IAACI, IADVL, JDA, NVvA, MSAI, OGDV, PSA, RAACI, SBD, SFD, SGAI, SGDV, SIAAIC, SIDeMaST, SPDV, TSD, UNBB, UNEV and WAO. The EAACI/GA(2)LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018 Jul;73(7):1393-1414. doi: 10.1111/all.13397.
- Fernandes RP, Centini G, Afors K, Puga M, Alves J, Wattiez A. Standard Approach to Urinary Bladder Endometriosis. J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):955-956. doi: 10.1016/j.jmig.2017.12.017. Epub 2017 Dec 28.
- Zhu L, Kim Y, Yang Z. The Application of Auriculotherapy to the Treatment of Chronic Spontaneous Urticaria: A Systematic Review and Meta-analysis. J Acupunct Meridian Stud. 2018 Dec;11(6):343-354. doi: 10.1016/j.jams.2018.08.209. Epub 2018 Sep 6.
- Zuberbier T, Abdul Latiff AH, Abuzakouk M, Aquilina S, Asero R, Baker D, Ballmer-Weber B, Bangert C, Ben-Shoshan M, Bernstein JA, Bindslev-Jensen C, Brockow K, Brzoza Z, Chong Neto HJ, Church MK, Criado PR, Danilycheva IV, Dressler C, Ensina LF, Fonacier L, Gaskins M, Gaspar K, Gelincik A, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Grosber M, Hamelmann E, Hebert J, Hide M, Kaplan A, Kapp A, Kessel A, Kocaturk E, Kulthanan K, Larenas-Linnemann D, Lauerma A, Leslie TA, Magerl M, Makris M, Meshkova RY, Metz M, Micallef D, Mortz CG, Nast A, Oude-Elberink H, Pawankar R, Pigatto PD, Ratti Sisa H, Rojo Gutierrez MI, Saini SS, Schmid-Grendelmeier P, Sekerel BE, Siebenhaar F, Siiskonen H, Soria A, Staubach-Renz P, Stingeni L, Sussman G, Szegedi A, Thomsen SF, Vadasz Z, Vestergaard C, Wedi B, Zhao Z, Maurer M. The international EAACI/GA(2)LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022 Mar;77(3):734-766. doi: 10.1111/all.15090. Epub 2021 Oct 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 736/DHYD-HDDD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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