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NCT Number: NCT06890260

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

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.

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Key information

Conditions

Allergic Rhinitis (Disorder) Electroacupuncture Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Microneedle Knife Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Electroacupuncture combined with Microneedle Knife

Other

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 patient can tolerate it, and the time of energizing is 30min; and then the patient takes the seated position, with his head hanging down low on the therapeutic pillow, and the therapeutic point of occipitocervical segment is selected, Then the patient is placed on the therapeutic pillow in a sitting position with the head hanging low, the treatment point of the occipitocervical segment is selected, the treatment point of the cervicothoracic junction is marked, and the micro-needle knife cuts and loose

Cetirizine hydrochloride tablets combined with nasal budesonide spray.

Drug

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 day, and then changed to 1 spray once a day after 1 week, which shall be used as the maintenance dose. The dosage will be increased or decreased at the patient's discretion according to the symptomatic condition during the course of treatment for a total of 4 weeks of treatment and observation. No other drugs for allergic rhinitis will be used during the treatment period.

Primary outcomes

  1. Total Nasal Symptom Score

    Time frame: 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.

    This scale will be performed by two trained raters to perform a Total Nasal Symptom Score#TNSS#, usually in the form of conversation and observation. After the examination, the two raters will score independently.TNSS score of 0 to 16 values, and higher scores mean a worse outcome.

Secondary outcomes

  1. Total Non-nasal Symptom Score

    Time frame: 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.

    This scale will be performed by two trained raters to perform a Total Non-nasal Symptom Score#TNNSS#, usually in the form of conversation and observation. After the examination, the two raters will score independently.TNNSS score of 0 to 5 values, and higher scores mean a worse outcome.

  2. Rhinitis Quality of Life Questionnaire

    Time frame: 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.

    This scale will be performed by two trained raters to perform a Rhinitis Quality of Life Questionnaire Score#RQLQ#, usually in the form of conversation and observation. After the examination, the two raters will score independently.RQLQ score of 0 to 144 values, and higher scores mean a worse outcome.

  3. blood serum

    Time frame: In the early morning at fasting state before and after 4 weeks of treatment

    In both groups, 5 mL of elbow venous blood will be drawn at room temperature in the early morning at fasting state before and after 4 weeks of treatment, and the serum will be separated by centrifugation at 3000 r/min for 15 min, and then stored in a refrigerator at -70℃ for measurement. Serum Eotaxin, Inter Cellular Adhesion Molecule-1(ICAM-1) and Eosinophil Cationic Protein(ECP) expression levels will be measured by enzyme-linked immunosorbent assay (ELISA).

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Qiu

CONTACT

[email protected]

+8618158508449

Sponsors and collaborators

Lead sponsor

Pengfei Qiu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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