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

NCT ID: NCT06890260

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-11
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cetirizine hydrochloride tablets combined with nasal budesonide spray group

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.

Group Type: EXPERIMENTAL

Cetirizine hydrochloride tablets combined with nasal budesonide spray.

Intervention Type: 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.

Electroacupuncture combined with Microneedle knife group

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.

Group Type: EXPERIMENTAL

Electroacupuncture combined with Microneedle Knife

Intervention Type: 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

Interventions

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 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

Intervention Type: OTHER

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 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis;

2. Aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity;

3. Not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment;

4. 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

1. Atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis;

2. Those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing;

3. Those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination;

4. Pregnant or lactating women, psychiatric patients, patients with malignant tumors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pengfei Qiu

OTHER

Sponsor Role: lead

Responsible Party

Pengfei Qiu

Attending Chinese Medicine Practitioner

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhejiang Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pengfei Qiu

Role: CONTACT

764360784@qq.com

+8618158508449

Facility Contacts

Pengfei Qiu

Role: primary

764360784@qq.com

+8618158508449

Other Identifiers

2025ZR001

Identifier Type: -

Identifier Source: org_study_id