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

NCT06890260 | Recruiting DMC

• 1 other identifier: 2025ZR001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis (Disorder); Electroacupuncture; Microneedle Knife

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score

  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.

  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.

Secondary Outcomes (3)

• Total Non-nasal Symptom Score

  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

  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

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

Study Arms (2)

Cetirizine hydrochloride tablets combined with nasal budesonide spray group

EXPERIMENTAL

The control group will be given oral cetirizine hydrochloride tablets and nasal budesonide spray with the following dosage: the starting dose is 2 sprays in each nostril twice daily, which is reduced to 1 spray in each nostril twice daily after 3 days, and then change to 1 spray once daily after 1 week, which will be used as the maintenance dose for a total of 4 weeks of treatment.

Drug: Cetirizine hydrochloride tablets combined with nasal budesonide spray.

Electroacupuncture combined with Microneedle knife group

EXPERIMENTAL

Subjects in this group will be treated with Electroacupuncture combined with Microneedle knife.The treatment time is 30 minutes each time, once every other day, and the treatment is carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments.

Other: Electroacupuncture combined with Microneedle Knife

Interventions

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

Electroacupuncture combined with Microneedle knife group

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.

Cetirizine hydrochloride tablets combined with nasal budesonide spray group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pengfei Qiu: lead

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310030, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Pengfei Qiu

CONTACT

+8618158508449; 764360784@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Chinese Medicine Practitioner

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)