The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle Knife

Официальное название

A Clinical Randomized Controlled Study of Electroacupuncture Combined With Microneedle Knife in the Treatment of Moderate to Severe Allergic Rhinitis

Обзор

Based on the inclusion and exclusion criteria, patients with allergic rhinitis who meet the requirements are selected as trial subjects, and the efficacy is clarified in a randomized controlled design trial. We will Use the total nasal symptom score as the primary outcome index, serum chemokine, intercellular adhesion molecule-1, eosinophil cationic protein, total non-nasal symptom score, and rhinitis-related quality of life scale as secondary outcome indexes, and oral cetirizine hydrochloride tablets and nasal budesonide spray as the control group, the efficacy of the subjects in the electroacupuncture combined with microneedle knife group and the drug group will be observed respectively before treatment, after 2 weeks of treatment, after 4 weeks, 1 month follow-up after the end of treatment, and 3 months follow-up after the end of treatment. 4 weeks later, 1 month follow-up after the end of treatment and 3 months follow-up after the end of treatment.

Вмешательства

• Другое Electroacupuncture combined with Microneedle Knife
  The patient takes the supine position, the acupoints take bilateral Yingxiang acupoints and upper Yingxiang acupoints, the tip of the needle is stabbed obliquely towards the root of the nose for 5-10mm, to the extent that there is a feeling of soreness and distension in the nose, and perform the flat tonic and flat cathartic method, the waveform of electroacupuncture is selected as sparse and dense wave, the frequency is 2/100Hz, the strength of the current is taken as the degree that the patien
• Препарат Cetirizine hydrochloride tablets combined with nasal budesonide spray.
  Cetirizine hydrochloride tablets (specification: 10mg\*24 tablets, Suzhou Sinochem Pharmaceutical Industry Co., Ltd., State Pharmaceutical License: H20030447) shall be given, 1 tablet daily. At the same time, nasal budesonide spray (specification: 64μg\*120 sprays, AstraZeneca Pharmaceuticals Co., Ltd, State Pharmaceutical License: J20090079) shall be used: the starting dose shall be 2 sprays in each nostril twice a day, and after 3 days, it shall be reduced to 1 spray in each nostril twice a da

Первичные конечные точки

• Total Nasal Symptom Score [Срок оценки: TNSS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.]

Вторичные конечные точки (3)

• Total Non-nasal Symptom Score [Срок оценки: TNNSS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.]
• Rhinitis Quality of Life Questionnaire [Срок оценки: RQLQ will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 3 month follow-up to evaluate the severity of the disease and the treatment effect.]
• blood serum [Срок оценки: In the early morning at fasting state before and after 4 weeks of treatment]

Критерии участия

Критерии включения

• Those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis;
• Aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity;
• Not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment;
• Those who voluntarily participated in this study and signed an informed consent form, and who were able to adhere to outpatient treatment for 4 weeks.

Критерии исключения

• Atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis;
• Those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing;
• Those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination;
• Pregnant or lactating women, psychiatric patients, patients with malignant tumors.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Hospital — Ханчжоу

Публикации

• Qiu P, Wu X, Ye N, Zhou X, Zhu J, Zeng X. The efficacy of electroacupuncture combined with Micro-Needle-Knife for allergic rhinitis: study protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Mar 13;13:1756690. doi: 10.3389/fmed.2026.1756690. eCollection 2026. PMID 41907282

Идентификаторы

NCT: NCT06890260 · 2025ZR001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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